Part B – Health Facility Briefing & Design

256 Pharmaceutical Factories

International Health Facility Guidelines

2024
Part B: Health Facility Briefing & Design
Pharmaceutical Factories

Table of Contents
256 PHARMACEUTICAL FACTORIES .................................................................................................. 3
1 INTRODUCTION................................................................................................................................ 3
2 FUNCTIONAL AND PLANNING CONSIDERATIONS................................................................................. 3
3 FUNCTIONAL RELATIONSHIPS ........................................................................................................ 11
4 DESIGN CONSIDERATIONS ............................................................................................................. 14
5 COMPONENTS OF THE UNIT ........................................................................................................... 20
6 SCHEDULE OF ACCOMMODATION ................................................................................................... 21
7 FURTHER READING ....................................................................................................................... 24

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256 Pharmaceutical Factories

1 Introduction
This Functional Planning Unit (FPU) covers the requirements of Pharmaceutical Factories. The
Pharmaceutical Factory is where pharmaceutical drugs are produced. The process involves
various stages from raw material receipt, weighting, sampling and production to packaging,
warehousing and dispatch. The staff working in different sections are required to follow different
flow patterns such as initial changing, gowning and going through one or more ante-rooms.
The facility may have a single or multiple production runs, requiring one or several production
rooms. The production rooms are regarded as clean rooms and subject to strict clean room
construction standards as well as air pressurisation regimes. The exact pressurisation regime will
depend on the type of products being produced, requiring either Positive or Negative Pressure
systems.
This guideline covers a range of scenarios and facility configurations. Any other permutations of
facilities should be based on the principles and examples provided in this FPU as well as the
type, chemistry and science behind the products being produced.
2 Functional and Planning Considerations
Operational Models
The Pharmaceutical Factory models will take into consideration the following:

Type of pharmaceuticals manufactured

▪ Sterile products
▪ Radio pharmaceuticals
▪ Non-sterile pharmaceutical products
▪ Biological active
▪ Aerosols
▪ Medicinal gases
▪ Derived from human blood or plasma
▪ Herbal medicinal products
▪ Liquids, creams or ointments
▪ Chemotherapy and other hazardous products

Operational factors within the facility

▪ Quantity being manufactured
▪ Personnel flows
▪ Material flows
▪ Process requirements

Hours of Operation
▪ The factory will generally operate 5 days per week from 8 am to 6pm daily. The exact hours
of operation should be determined by the Operational Policy, trade license conditions (if any)
and operational licence granted (if any).
▪ Operational hours can also be adjusted considering production need and urgent requests.

Functional Zones
The Pharmaceutical Factory shall include the following main areas:
▪ Raw material receipt and store

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▪ Sampling and Weighing
▪ Production
▪ Packaging
▪ Warehousing
▪ Staff Amenities
▪ Administration
The following standard rooms/areas are required:
▪ Entry/ Reception/ Lobby area
▪ Loading Docks for unloading raw materials and loading of finished products with a Control
Room to supervise material movement
▪ Raw Material Warehouse, for storage of raw materials used for production
▪ Sampling area, to perform a quality check on the materials and primary packaging used
during production
▪ Weighing area (optional), for dispensing of materials to be used during production of a batch
▪ Primary Staff Change Room, gender separated, where personnel will change from their
outdoor clothing to their facility uniforms
▪ Production/ Clean Corridor (only required if multiple production rooms are provided)
▪ Airlock(s)/ Gowning Rooms (Gown-up and Gown-down)
▪ Production Clean Rooms
▪ Secondary Packaging Area
▪ Warehouse for storing of final packaged pharmaceuticals
▪ Administration / Office/ Support Areas:
- Offices and workstations for key personnel, including Quality Assurance personnel and
Service line managers
- Meeting room
▪ Staff Amenities:
- Staff Room
- Locker area (may be shared with primary staff change room)
- Toilets and Showers, gender separated (may be shared with primary staff change room)

The above zones are briefly described below.

Entry/ Reception/ Lobby Area

Personnel and visitors should enter and exit the factory via a lobby area. Staff within the reception
area shall control the access of personnel and staff into the factory. Optionally, visitor and staff
access may be separated, but both monitored by a reception or security counter with control over
who enters the production areas of the facility.

Loading Docks
There will be a minimum of two loading docks:
▪ A dock for unloading the raw materials. This will be conveniently connected to the Raw
Materials Warehouse
▪ A dock for loading the finished products and packaged pharmaceuticals from the Warehouse
for distribution
Both docks will be monitored from a Control office to control and monitor the movement of the
materials and products.
The two docks may be separate for maximum operational efficiency and quality control.

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However, based on the design geometry, the two docks may be side by side with access off the
same service road. However, the flows of goods through the two docks will be different following
the diagrams in this FPU.

Raw Material Warehouse

Items from the loading dock will be transferred to the Raw Material Warehouse or Store.
▪ This area will be temperature and humidity controlled to maintain the viability of the raw
materials.
▪ Raw materials should be stored appropriately depending on their individual requirements,
whether at room temperature, in refrigerators or freezers etc.
▪ For Hazardous materials:
- These must be unpacked from shipping containers in an environment that is at negative
pressure relative to the surrounding areas.
- They must be stored separately from other inventory and at negative pressure storage
conditions to prevent exposure to personnel. Should the volume of the hazardous material
be small, they can then be stored within the production room itself.
- A refrigerator used to store hazardous materials should preferably have an exhaust
installed next to the compressor or behind the refrigerator.
- Storage of the material should ensure no spillage or breakage in the event of any natural
disaster.
▪ The Warehouse or Store shall be security controlled.
▪ The temperature control for the warehouse should be alarmed. It should have both local and
remote display and monitoring of the alarm.

Sampling Area
The Sampling Area is used to perform a quality check on the materials to be used during
production including the primary packaging and the processing agents etc. A small quantity of a
batch of the material intended to be used during production will be assessed.
▪ The Sampling Room provides a controlled clean environment to maintain the sterility and
viability of the materials whilst being exposed to the environment during sampling.
▪ This area should be temperature and humidity controlled.
▪ The HVAC system for this area should have the same pressurisation classification as the
production room where the material or products shall be exposed to the environment.
▪ The Sampling Room should prevent cross-contamination of the materials.
▪ The facilities should protect personnel during the sampling process.
▪ The transfer of material from the Raw Material Warehouse or store into the Sampling Room
should be via a material airlock or two-door interlocking pass-through hatch.
▪ Warehouse staff should access the sampling room via a Staff Gowning Room with cross over
bench.
▪ The Sampling Room shall have a laminar flow hood to protect the material from
contamination during sampling.
▪ A clean up room for washing the equipment used during sampling should be available, either
accessed from within the Sampling room or in close proximity to the Sampling Area.
▪ Lighting within the Sampling Room should be selected taking into consideration light-
sensitive material that may be inspected.
▪ The materials can be transferred from the Sampling area to the Production Area via a
Material Airlock or two-door interlocking pass-through hatch.

Weighing Area
The optional Weighing Area is where raw materials are weighed and transferred to clean
containers for use in the production area. The requirement for a dedicated Weighing Area will

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depend on the operational policy of the facility and product types. As an alternative Weighing may
also occur in the Production Room.
The Weighing Area will have three main sections separated by material airlocks:

▪ Pre-staging
The external packaging of the materials to be weighed are removed here and the containers are
wiped down. The pallet or cart is then moved to the material airlock by warehouse personnel that
then exit the airlock. Weighing personnel then enter the material airlock, remove the material and
transfer it to the weighing area.
▪ Weighing Room
The materials are weighed and dispensed here. This is done under a laminar flow hood. Any
unused material is returned back to the pre-staging area and can be stored there or returned to
the warehouse. Once dispensing is complete, the weighing personnel transfer the materials on a
clean cart to the material airlock leading to the production area. The cart is then picked up by
personnel to the post-staging area.
▪ Post-staging
Post-staging is recommended if multiple weighing areas are used for different product types.
Materials are then transferred from the Post-staging area to the Production Room via the
Production Room airlock. For small quantities and only a single weighing area, Post-staging may
not be required.
The Weighing Area should also consider the following requirements:
▪ There should be a Unidirectional flow of materials.
▪ The area should be temperature and humidity controlled.
▪ Hazardous and non-hazardous material should be kept separate.
▪ The HVAC system for this area should have the same area pressurisation regime (negative
or positive) as the production room where the material or products shall be exposed to the
environment.
▪ During weighing, any dust produced shall be contained and the operator should be protected.
▪ A clean up room for washing the equipment used during weighing should be available, either
accessed from within the Weighing Room or in close proximity to the Weighing Area.

Primary Staff Change Rooms

▪ Toilet facilities should only be present in the primary change rooms

▪ At least one shower per change room should be provided.
▪ Staff Change Rooms must be gender separated.
▪ Staff change rooms should have lockers for the secure storage of street clothes.
▪ It is recommended that visitors should have separate change rooms to staff, however this is
not mandatory.
▪ Administrative staff may not require changing into uniforms unless they are required to
periodically visit the Production Rooms or the Sampling Room.
▪ The Change Rooms for the Administrative staff may be separated for convenience, if
preferred.

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Production/ Clean Corridor

The Production/ Clean Corridor should be provided if more than one Production Clean room is
required. The function of the Clean Corridor is to link the Raw Material Warehouse, Post Staging
and Sampling areas to multiple Production Clean Rooms.
When the production involves the potential creation of dust, the Clean Corridor also serves to
contain any dust produced in the Production Rooms. In such situations the corridor shall be at a
higher pressure compared to the airlock leading into the Production Clean Room.
If only a single production room is intended, the provision of a Production Clean Corridor is not
mandatory. In such situations, the Materials Airlock can be used instead of the Production Clean
Corridor.
The Production/ Clean Corridor relative pressurisation against the Airlock/ Gowning Room will be
Neutral pressure. Therefore, the Airlock/ Gowning Room may be either positive or negative
compared to the Neutral pressure.
See below regarding the requirements for the air pressurisation of the Airlock/ Gowning Room.

Airlock/ Gowning Room

This Airlock/ Gowning Room is required for access to each Production Clean Room. It is located
between the Production Clean Corridor or Materials Airlock and the Production Clean Room.
Based on the facility operational policy and the type of products being produced, either one or two
Airlock/ Gowning Rooms is required per production clean room. One is to be used for Gowning
Up and the other for Gowning Down. This, however, is not mandatory and for many production
facilities a single Airlock for both Gowning Up and Down is sufficient. The Functional Relations
Diagrams in this FPU indicate the separate Gown-Up/ Gown-Down Airlocks.
The Airlock/ Gowning Room requires the following provisions:
▪ Electronic interlock door system should be provided to prevent the opening of both doors in
the Airlock at the same time.
▪ The staff should change into sterile gowns prior to entering the Clean Room.
▪ The staff should remove the sterile gowns after exiting the Clean Room.
▪ There should be no toilets or showers within the Airlock/ Gowning Room. Hand wash basins
are optional but must be located at least one metre away from the entrance of the production
room. Hand sanitizer dispenser is mandatory.
▪ Airlocks used for personnel should be separated from those used for material. If this is not
physically possible, then the use of the same airlock should be time-separated.
▪ The HVAC should be appropriately designed to achieve the pressurisation regime required
for the Production Clean room connected to the Airlock and described below.
▪ Positive Pressure Regime - If the Production Room is required to be under positive pressure,
to protect the products from possible contamination, then the Airlock should also be positive
pressure but at a level lower than the Production room. Therefore, it should be at relative
negative pressure compared to the Production Room. The Airlock, in turn should be at a
higher pressure than the Production / Clean corridor, which is at Neutral pressure. Therefore,
any movement of air will be from Production Room to the Airlock and from Airlock to the
Production / Clean corridor. This is referred to as a uni-directional flow of air towards the
room with the lowest pressure.
▪ Negative Pressure Regime - If the Production Room is required to be under negative
pressure to prevent any airborne toxic material or dust reaching other areas, the Airlock
should also be negative pressure but higher than the Production Room. Therefore, it will be a
relative positive pressure compared to the Production Room. The Airlock, in turn should be at
a lower pressure than the Production / Clean Corridor, which is at Neutral pressure.
Therefore, any movement of air will be from the Production / Clean Corridor to the Airlock
and from the Airlock to the Production Room. This is referred to as a uni-directional flow of air
towards the room with the lowest pressure.

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Production Clean Room
The Production Clean Room is where the pharmaceutical products are manufactured. The
Production Clean Room may be used for a variety of products, using different raw materials,
machinery and processes. All permutations of the production cannot be anticipated or covered in
these Guidelines. The Clean Room classification is dependent on the type of product being
manufactured as well as the chemistry and science behind approved products. The common
features of the Production Clean Room are as follows:
▪ The HVAC system and the air pressurisation regime should be appropriately designed to
achieve and maintain the required cleanroom condition and uni-directional flow of air for the
products being manufactured.
▪ The room should have temperature and humidity control with visible and audible alarms. To
maintain the viability of the pharmaceutical the selected temperature and humidity must meet
the requirements of the components and the final product.
▪ The room should contain laminar flow cabinets and/ or isolators for any sterile and/ or
hazardous product manufacturing.
▪ A fixed window should be provided into the clean room from an adjoining corridor for viewing
the processes and supervision of the full area without entering the room.
▪ Alternatively high-resolution CCTV cameras for remote monitoring should be provided.
▪ The facility to comply with room design and construction requirements in relevant Clean
Room standards for pharmaceutical manufacturing of the specific products.
▪ Some products require manufacturing under Positive Pressure to protect the raw materials or
finished products from contamination. However, some products require manufacturing under
Negative Pressure to contain potentially hazardous materials or dusty material from being
released to the external environment before the production is finalised and the products are
stabilised and packaged. In the case of biologically active products, these are classified into
four Biosafety Risk Groups; Group 1 – Organisms that are unlikely to cause disease is a
healthy individual ; Group 2 – Organisms that can cause disease but under normal usage are
unlikely to spread, and usually have an effective treatment available; Group 3- Organisms
that can cause severe human disease and can spread but an effective treatment is available
and ; Group 4 - Organisms that can cause severe human disease and can spread and an
effective treatment is not available. Refer to the below table to determine the required
Pressure Regime to be adopted based on the type of pharmaceutical being produced.

Pressurization
Pharmaceutical Type Notes
Regime*
Aerosols Negative
Biologically Active Negative Pressure For Biosafety Risk Group 3 and/ or 4 organisms - Air
for Biosafety Risk should not be recirculated to any other area in the facility
Group 3 or 4 and should be exhausted through HEPA filters.
organisms Inactivation of the pathogen in the exhaust air is
mandatory
Biosafety Risk Group 4 organisms – a dedicated non-
circulating HVAC system is required
Chemotherapy and other hazardous Negative
products

Derived from human blood or plasma Positive Where blood products are handled, these areas should
be completely separated, physically, from areas where
non blood products are being handled

Herbal medicinal products Positive

Liquids, creams or ointments Positive
Medicinal gases Negative
Non-sterile pharmaceutical products Positive or Neutral

Radio pharmaceuticals Negative Airborne or volatile radiopharmaceutical must be

produced under a Negative Pressure regime

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Pressurization
Pharmaceutical Type Notes
Regime*
Sterile products Positive
IV’s Positive
Dietary Supplements Positive
Medical Devices Positive If the devices include chemical capsules, then follow the
requirements of the chemicals

* Any other pharmaceutical type that is deemed to be of a hazardous nature must be produced
under a negative pressure regime

▪ Once the pressurisation regime is determined, the pressurisation of two adjoining areas
leading to the Production Room, being Production Corridor and Airlock/ Gowning should be
progressively positive or progressively negative to create a uni-directional flow of air.
▪ Work benches are to be free-standing, preferably mobile, and in stainless steel. Stainless
steel trolleys can be provided for minimal storage.
▪ The different operations within the production room need to be separated to prevent
contamination and errors.
▪ Primary packaging of the product is done within the clean room.
▪ After manufacturing and primary packaging, the product is transferred to an exit air lock that
leads to the Secondary Packaging area.

Secondary Packaging
Within the secondary packaging area, an outer packaging is applied to the primary packaged
product for extra protection, and to prepare it for storage and transportation. From here the
packages are sent to a bulk store or warehouse.
The Secondary Packaging area should have the following features:
▪ Shelving system for the temporary storage of the packages
▪ Benches for the preparation of secondary packages
▪ Optional conveyor belts for the transportation of the boxes within the Secondary Packaging
area
▪ At least one open workstation or office for the management of the Secondary Packaging area
▪ Various machines and devices for labelling, tagging and quality control
▪ The Secondary Packaging should be temperature and humidity controlled
▪ The products should not be removed or exposed to the air

Warehouse
The finished product is stored within a warehouse or bulk store. The Warehouse should have the
following features:
▪ The Warehouse should be temperature and humidity controlled.
▪ The conditions of storage should follow the product’s specific requirements.
▪ Tertiary packaging, if necessary, can be conducted within the Warehouse before dispatch.
▪ The Warehouse requires security and controlled access.
▪ The Warehouse should be located with ready access to the loading dock area.
▪ A control office or open workstation should be provided to oversee the access to the dock
and manage the loading of the products for delivery.

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Equipment Clean Up
This area is where the items from the various areas, including the Production Room, Weighing
Room and Sampling Room, are sorted, rinsed and disposed of prior to disinfection and when
necessary, sterilising. It is essential that the risk of contamination of the equipment after sterilising
is minimized. For further information on guidelines for this area refer to the Sterile Supply Unit
FPU.

Staff Amenities
Staff Amenities such as Staff Room, Toilets and Showers shall be located prior to the Primary
Change Area. Optionally the Staff Amenities for the Administration area may be separated from
the production and support staff. The staff amenities include the following provisions:
▪ Staff Room and any dining areas
▪ Toilets, Shower and Lockers within the Primary Change Rooms

Administration
Administration area includes the normal function of facility management, accounting, payroll, HR
etc. Its exact requirements are based on the type of facility and the management policy. A typical
administration area will include the following:

▪ Management Offices
▪ Open workstations
▪ File store
▪ Photocopy/ supply store
▪ Meeting room(s)
▪ Optional separate staff toilets and staff room

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3 Functional Relationships
A Functional Relationship can be defined as the correlation between various areas of activity
whose services work together closely to promote the delivery of services that are efficient in
terms of management, cost and human resources.
External
The components of the facility should be arranged on the site to achieve the required
relationships described above and indicated in the Functional Relationship Diagrams below. The
provided diagrams are not Architectural plans and can be stretched, rotated and moved whilst still
achieving the connectivity and flows implied and required.
For example, there are planning solutions where the in-coming and out-going loading docks can
be arranged side by side whilst achieving all the other relationships.
As Pharmaceutical factories may be vastly different and specialise in the production of different
products, there may be one or more production rooms (or halls). It is assumed that a modular
configuration may be preferred. The specific requirements of each production room and the
immediate support rooms such as Air lock/ Gowning rooms form one “module”. If the facility has
multiple product lines, running concurrently, then multiple modules can be added. This is also
implied in the Functional Relationship Diagrams below.
To note, areas where blood products are being processed need to be completely separated
physically from areas where non blood products are being handled.
The Warehouse and Raw Materials Store may be located in separate buildings on-site, but the
preferred location is with direct access to the main Production building. They should be located
with ready access to a receiving Loading Dock area.
Internal
The Internal planning of the factory should consider the unit’s functional areas/zones.
Access points provided for the following people should be carefully considered:
▪ Visitors to the Unit
▪ Administrative staff who will not normally enter the production facilities
▪ Pharmaceutical Factory Staff
▪ Supplies delivery (Unloading and Loading Docks)
The internal flows for the production staff progress from outside the facility through the entrance
point, primary change, then Airlock/ Gowning and finally the Production Clean Room.
The products, but not the people, flow out of the Production Clean Room to the Secondary
Packaging and finally to the Warehouse and dispatch loading dock.
Raw products arrive at the receiving dock and may be stored, sampled, weighed and transferred
to the Production Clean Room via an air lock.
Functional Relationship Diagram

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4 Design Considerations
General
Design of the factory should consider the need for security and sterility of the necessary areas.
Environmental Considerations
Operational Considerations
▪ Maintenance workshops, if provided, should be separated from production areas.
▪ Whenever parts and tools are stored in the production area, they should be kept in rooms or
lockers reserved for that use.
▪ Storage areas should be of sufficient capacity to allow orderly storage of the various
categories of materials and products with proper separation and segregation.
▪ Receiving areas should be designed and equipped to allow containers of incoming materials
to be cleaned, if necessary, before storage.
▪ Highly active and radioactive materials, narcotics, other dangerous medicines, and
substances presenting special risks of abuse, fire or explosion should be stored in safe and
secure areas as per the requirements of the responsible Authorities.
▪ The production of certain other highly active products, such as some antibiotics, hormones,
cytotoxic substances and certain non-pharmaceutical products, should not be conducted in
the same production room/area.
▪ Quality Control (QC) laboratories (if provided) should be separated from production areas.
Areas where biological, microbiological or radioisotope test methods are employed should be
separated from each other. For Laboratories refer to the Laboratory Unit within these
Guidelines.
▪ QC laboratories should be designed to suit the operations to be carried out in them. There
should be separate air supply to laboratories and production areas.
▪ A separate room may be needed for certain instruments to protect them against electrical
interference, vibration, contact with excessive moisture and other external factors, or where it
is necessary to isolate the instruments.
▪ Rejected materials and products should be clearly marked as such and stored separately in
restricted areas.
▪ Recalled products should be identified and stored separately.
▪ Provision should be made for the proper and safe storage of waste materials awaiting
disposal. Refer to Waste Management Unit within these Guidelines.

Acoustics
For factories that utilise equipment that produce noise exceeding the maximum allowable levels,
acoustic treatment may be required.

Natural Light/ Lighting

Natural lighting must be avoided, except within offices and administrative areas. This is to ensure
the preservation of product viability and to minimise temperature variations.
▪ High quality general and task lighting is essential to ensure complex tasks can be safely
achieved.
▪ Some raw materials are affected by the wavelength of light they are exposed to, degrading
them and/ or impacting their usability. The type of light installed within the Sampling,
Weighing and Production areas, or other areas where the raw materials are exposed to light,
needs to take into consideration the requirements of the materials.

Accessibility – External
▪ There should be weatherproof loading and unloading docks to ensure protection of delivered
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supplies and outgoing delivery of finished manufactured pharmaceuticals.

Doors & Clearance

▪ Corridors and door openings within the Warehouse and where materials are transported shall
provide sufficient clearance for large items and equipment from bulk stores. The corridor
should permit two-way traffic of bulky items.
▪ Configuration of factory benches, furniture, fixtures and equipment must not impede
emergency access to an exit. A pathway, leading to the face of an exit must have the
minimum width as required by the local fire services codes (not covered in these Guidelines).
▪ Sufficient space around production equipment for maintenance must be considered during
the design phase.
▪ Doors to the Production Areas must be adequately sized to accommodate equipment located
in the Production Clean Room such as fume hoods, automated equipment and the like.
▪ Door sweeps and door seals should not be installed at doors between the Production Clean
Room and the Airlocks.
▪ Access doors to the Production Clean Room should be handsfree.

Ergonomics/ OH&S
▪ Ergonomics must be considered in the internal design of the Unit for staff health and safety.
Heights and depths of benches need to allow staff to efficiently work from standing and
seated positions. Consideration must be given to storage of supplies at suitable working
heights.
▪ Consideration should be given to the need for manual handling devices such as dock
levellers and lifters. A well-designed and equipped work area will eliminate injuries resulting
from manual handling.
▪ Refer also to Part C – Access, Mobility and OH&S of these Guidelines for additional
information.

Size of the Factory

▪ The size of the Factory is determined by the Service Plan establishing the intended scope
and complexity of manufacturing.

Safety and Security

▪ The factory must be designed and constructed to prevent unauthorized access through
doors, windows, walls and ceilings. All entrances and exits shall be secured. An Intrusion
Detection Alarm System is required within the factory to allow for a 24-hour monitoring by a
central security team on-site.
▪ An intercom or call bell should be located at the dock entrance area to announce deliveries
when doors are closed.
▪ Where required, concave directional mirrors along corridors and bends should be provided to
avoid collision of oversized trolleys, motorised transporters and staff.
▪ Security measures for consideration includes the following:
- Electronic door controls
- Movement sensors
- CCTV cameras: CCTV cameras must be installed with an unobstructed view of the
required areas
▪ Locking mechanism, where required in the Factory, can be in the form of controlled access
cards, keypads or physical keys.
▪ Design of the Warehouse and Stores should ensure that storage areas are free from insects
and vermin.
▪ Flammable liquids, chemicals and reagents used must be stored according to relevant local
regulations.

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▪ Storage, handling and disposal for radioactive and other such materials must be considered
depending on the services provided.
▪ Radiation detection and measuring devices must be provided as per the relevant local
authority requirements.
▪ Exhaust should be provided in rooms for storing and recharging of pallet jacks, motorised
transporters and other equipment depending on battery type to avoid build-up of noxious
gases.
▪ Any devices, equipment or rooms which must be controlled within strict parameters such as
temperature must be alarmed. Such alarms must be both visual an audible and capable of
monitoring from a remote area permanently manned by staff.
Refer also to Part C – Access, Mobility, OH&S of these Guidelines for additional information.

Finishes
Finishes within the Warehouse and Stores should consider the following:
▪ Door & wall protection shall be installed to prevent damage to walls caused by all types of
trolleys, lifting/transport equipment and movement of large items. Sturdy wall protection such
as rubber or timber wall protection is recommended to withstand impacts from trolleys, pallet
jacks and other bulky transporting equipment. Solid core laminated doors with stainless steel
door and door frame protection panels is recommended to avoid chipping and breakage.
Alternatively, solid core doors with high quality enamel paint can be used with additional
proprietary door protection on the leaf and frame.
▪ Floor finish is to be slip resistant, impervious, easy to clean and hardwearing. Movement of
large equipment and lifting/ transporting equipment are to be considered when choosing
appropriate floor finish.
In Clean Rooms, Weighing and Sampling Rooms the following should be considered:
▪ As a minimum, all surfaces including floors, walls, ceilings, doors and fixtures should be
uniform, gap free, sealed, inspectable and easily cleanable around all edges and corners with
aggressive cleaning agents.
▪ The internal room finishes, the benches and any fixtures and fittings should allow for the easy
cleaning of all surfaces by high pressure water and cleaning agents between the product
runs.
▪ Work surfaces should be smooth, monolithic, chemical resistant and impervious to moisture.
▪ Work benches are to be free-standing, preferably mobile, and in stainless steel. They shall be
seamless to prevent contamination from spillage. Splashback or coved upturns must be
provided when the benchtop abuts a wall.
▪ There should be no gaps between attached elements, or any such gaps must be sealed.
▪ Stainless steel trolleys can be provided for minimal storage
▪ High performance 2-coat epoxy paint, preferably with antibacterial properties, must be
applied to the walls to form an impervious, scrubbable, continuous monolithic finish.
Alternatively, full height wall vinyl with fully welded joints may be used.
▪ High performance 2-coat epoxy paint must be applied to gypsum, cement board or similar
ceiling materials to form a continuous monolithic finish. Drop-in tiles or materials with joints
and gaskets should be avoided.
▪ For flows, homogeneous vinyl flooring (or similar) with hot-welded joints may be used. High
performance 2-coat epoxy paint to the floors is also acceptable.
▪ The joints between floors and walls, walls to ceilings and internal corners of walls should be
rounded for easy cleaning by a minimum of 25mm radius.
▪ Light fittings within the clean rooms should be mounted flush and sealed but openable via
Allen keys for maintenance. Any access hatches required in the ceiling must be hermetically
sealed and openable via alan keys.
▪ Any other finish should be at least equal or better than these products. Nothing in these

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guidelines dictate a requirement for panelised metal walls or ceilings. If, however, such
finishes are preferred, the jointing system must ensure that the surfaces are impervious, gap
free, fully sealed and smooth with no rebates, grooves etc.
▪ In other areas the following should be considered:
▪ Wall and door protection should be installed to prevent damage to walls caused by mobile
equipment such as trolleys.
▪ Floor and walls should be anti-static, heat resistant, anti-bacterial, anti-fungal and chemical
resistant. All joints in flooring must be sealed and coved at the edges (against walls or fixed
joinery) where possible. Water and chemical resistance are also important characteristics of
selected flooring. Walls shall be painted with lead free paint, or prefinished for easy cleaning.
▪ Wall finish treatments must not create ledges or crevices that can harbour dust and dirt.
Refer to Part C – Access, Mobility and OH&S of these Guidelines for more information on wall
protection, floor finishes and ceiling finishes.

Fixtures, Fittings and Equipment

▪ Equipment, furniture, fittings should be selected to ensure that users are not exposed to
avoidable risks or injury.
▪ Specialised equipment will require services and installation according to manufacturers’
specifications, in particular:
- Space requirements may vary according to equipment selected
- Structural assessment may be required for large equipment items
- Space requirements for maintenance of equipment must be considered

▪ A safety shower and eyewash should be provided close to production areas for harmful spills.
However, safety showers and eyewash should not be provided directly within the Production
Clean Rooms.
▪ Refer to Part C – Access, Mobility and OH&S of these Guidelines and Standard Components
of individual rooms for specific information related to fixtures, fittings, and equipment.

Radiation Protection
▪ Radiation protection requirements should follow the local authority requirements and
guidelines.

Window Treatments
▪ Window treatment should be installed to external windows to control sunlight and glare to
administrative areas and offices.
▪ The Production Clean Rooms, Sampling and Weighing rooms should avoid windows and
natural light.
▪ In other areas if windows are used, curtains and horizontal blinds should be avoided.
Building Services Requirements
Information and Communication Technology
The Pharmaceutical Factory requires reliable and effective IT / Communications service for
efficient operation. The IT design should address:
▪ Voice/ data cabling and outlets for phones, computers and equipment, where required
▪ Network data requirements and wireless network requirements in service areas of the facility
▪ CCTV surveillance
▪ Intercom system between positively or negatively pressurized rooms and their adjacent
spaces
▪ Data entry including reporting

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▪ Bar coding of supplies within the warehouse and stores
▪ Optional availability of Wi-Fi for staff

Power
All major equipment within the Production Area should be connected to emergency power.
Computerized systems of the production equipment must retain the system set up and/ or run
values, therefore they must be connected to uninterrupted power.
HVAC systems serving production of hazardous pharmaceuticals must be operated on
uninterrupted power.

Heating Ventilation and Air-conditioning (HVAC)

▪ All Storage, Warehousing, Sampling, Weighing, Production and Packaging Areas must be
fitted with temperature and humidity controls. Temperature and humidity upper and lower
limits for the different areas must be selected according to the requirements of the materials
and products, in order to maintain their viability. Where identified, the temperature and
humidity should be maintained within the defined limits of product viability.
▪ In the absence of such information, the temperature and humidity should be set at the below
values:

Temperature Humidity

20°C 60%

▪ Visible alarms are required to monitor the temperature range and humidity levels
▪ Exhaust should be provided in rooms for storing and recharging of pallet jacks, motorized
transporters and other equipment depending on battery type to avoid build-up of noxious
gases.
▪ Special air-conditioning systems that provide either positive pressure or negative pressure
will be required. The HVAC system should support the grade / classification of the clean room
and all adjacent rooms, as per production requirements and national and international
standards.
▪ Where required, the HVAC system should be set for either positive or negative pressure as
indicated in this FPU. The system cannot be switchable between positive and negative
pressure.
▪ The HVAC system must be designed to control parameters such as temperature, relative
humidity, airflow and pressure differential and these should be monitored.
▪ Freestanding humidifiers, dehumidifiers and air conditioners are prohibited within the
Production areas
▪ Audible and visual alarms for pressure, temperature and humidity within the clean rooms and
airlocks are required. Such alarms must be capable of remote monitoring.
▪ Dust removal should be designed into the HVAC system where necessary. As much as
possible, dust should be removed as close as possible to the source in order to limit its
dispersal. A dust extractor should be dedicated per room to avoid back flow resulting in cross
contamination.
▪ Radioactive gases and vapours should be monitored with alarm systems. Separate air
handling units are required for these, and recirculation of air is prohibited.
▪ HVAC air blowers in the ceiling should be located to precent air currents within laminar
airflow cabinets and other such equipment.
▪ Air return grills should be placed at low levels on the wall and distributed throughout the
room.
▪ All HVAC units and systems are to comply with services identified in the Standard

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Components and Part E – Engineering Services.

Hydraulics
▪ Warm water should be supplied to hand wash basins, eye-wash stations and emergency
shower.
▪ Provision of purified water is required for cleaning of areas including the clean room,
weighing area and sampling areas.
▪ For cold, warm & hot water technical details, refer to Part E – Engineering Services in these
Guidelines.
▪ Drains should be avoided where possible and should not be present within the Clean Rooms
or Airlock/ Gowning Rooms.
▪ There should be no sources of water within the Clean Rooms.
▪ Sprinklers within the Clean Room should be recessed and covered.
Infection Control
Infection Control measures applicable to the Factory will involve proper handling of products and
materials to prevent contamination of staff and material as well as cross contamination of
products and materials.
Standard precautions apply to the Factory areas and Personal Protective Equipment (PPE),
including protective clothing, gloves, masks, and eye protection, will be available close to all
processing areas and clean rooms.

Hand Basins
▪

For further information refer to Part D – Infection Control in these Guidelines.

Emergency Shower and Eye-wash Station
▪ Weighing, Sampling and Production Clean Rooms must have access to at least one
emergency shower and eye-wash station.

Antiseptic Hand Rubs

▪ Antiseptic hand rubs should be located so they are readily available for use.
▪ Antiseptic Hand Rubs, although very useful and welcome, cannot fully replace Hand Wash
Bays.

Chemical Storage
▪ Storage for chemicals and reagents should be physically separated from other storage in the
Factory with designated cabinets. Chemicals and reagents should not be stored in cabinets if
they are fixed above a sink/s.
▪ The storage of flammable materials must be subject to the requirements of local Civil
Defence or fire authorities.

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5 Components of the Unit
Standard Components
▪ Standard Components are typical rooms within a health facility, each represented by a Room
Data Sheet (RDS) and a Room Layout Sheet (RLS). Sometimes, there are more than one
configuration possible and therefore, more than one room layout sheet can be found in the
Standard Components for a room with same function. They may differ in room size and/or the
requirement of FF & FE items.
▪ The Room Data Sheets are presented in a written format, describing the minimum briefing
requirements of each room type divided into the following categories:
▪ Room Primary Information; includes Briefed Area, Occupancy, Room Description and
relationships, and special room requirements.
▪ Building Fabric and Finishes; identifies the fabric and finish required for the room ceiling,
floor, walls, doors, and glazing requirements.
▪ Furniture and Fittings; lists all the fittings and furniture typically located in the room; Furniture
and Fittings are identified with a group number indicating who is responsible for providing the
item according to a widely accepted description as follows:

Group Description
1 Provided and installed by the builder
2 Provided by the Client and installed by the builder
3 Provided and installed by the Client

▪ Fixtures and Equipment; includes all the serviced equipment typically located in the room
along with the services required such as power, data and hydraulics; Fixtures and Equipment
are also identified with a group number as above indicating who is responsible for provision.
▪ Building Services; indicates the requirement for communications, power, Heating, Ventilation
and Air conditioning (HVAC), medical gases, nurse/ emergency call and lighting along with
quantities and types where appropriate. Provision of all services items listed is mandatory.
▪ The Room Layout Sheets (RLS’s) are indicative plan layouts and elevations illustrating an
example of good design. The RLS indicated are deemed to satisfy these Guidelines.
Alternative layouts and innovative planning shall be deemed to comply with these Guidelines
provided that the following criteria are met
▪ Compliance with the text of these Guidelines
▪ Minimum floor areas as shown in the Schedule of Accommodation
▪ Clearances and accessibility around various objects shown or implied
▪ Inclusion of all mandatory items identified in the RDS
▪ Standard Components have considered the required design parameters described in these
Guidelines. Each FPU should be designed with compliance to Standard Components – Room
Data Sheets and Room Layout Sheets, nominated in the Schedules of Accommodation in
Appendices of this FPU.
Non-Standard Components
Entrance Lobby
The Entrance Lobby adjoins the Entry Airlock, Main Reception and Waiting areas. Convenient
access to public amenities is required.
Key consideration in the Entrance Lobby are:
▪ Selection of floor finish to reduce the risk of slips and falls to visitors and staff
▪ Provision of good internal lighting
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▪ Sufficient signposting and directional signs to identify key areas within the zone including
Reception, Enquiries, Public Amenities, Lifts and circulation routes

Sampling Room
The Sampling Room is a Clean Room used to perform a quality check on a small quantity of a
batch of the material to be used during production.

Pre-Staging
This area is where the external packaging of the materials is removed and then wiped down in
order to be weighed.

Weighing
The Weighing room is a Clean Room where the materials from the Raw Materials Warehouse are
weighed and then transferred to the Production Room.

Post-staging
This area adjoins the airlock upon exiting the Weighing area and is used to organise the different
materials to be transferred to the different Production Clean Rooms, if there are multiple
Production Rooms. This area is optional.

Production Room
A Clean Room where the pharmaceutical product is manufactured.

Secondary Packaging
An area where the secondary packaging is applied to the finished product.

6 Schedule of Accommodation
The Schedule of Accommodation (SOA) identifies the rooms required in the Unit along with the
quantity and the recommended room area. The sum of these room areas is the Sub Total and
Total Departmental areas with a recommended circulation percentage. The circulation
percentage represents the area required for internal corridors and is a target for efficient planning.
SOAs and room sizes are developed for typical units and are organised into the functional zones
applicable to the Unit. Not all rooms identified are mandatory requirements and optional rooms
are indicated. Quantities of rooms may need to be proportionally adjusted to suit the desired unit
size and service needs.
The Schedules of Accommodation are developed for particular levels of service known as Role
Delineation Level (RDL) and numbered from 2 to 6 (including in-between numbers such as 4-5).
Level 2 represents uncomplicated health facilities, ascending to level 6 representing complex
specialist services and hospitals. Refer to the full Role Delineation Framework in these guidelines
for a full description of the RDL’s identified. RDL Levels not listed are not applicable for this
service.

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Pharmaceutical Factories
ROOM/ SPACE Standard Component 2 Production Rooms NA Remarks
Unit Size Room Codes

Entry/ Reception
Reception/ Clerical recl-5-d or similar 1 x 5
Entrance Lobby NS 1 x 20
Change - Staff (M/F) chst-14-i chst-20-i similar 2 x 20
Toilet - Staff (M/F) wcst-i 4 x 3
Raw Materials Warehouse
Loading Dock lodk-i 1 x 0 External space
Stork - Bulk stbk-40-i or similar 1 x 40 Size according to requirements
Store - Refrigerated stref-5-i stref-10-i or similar 1 x 5 Optional. May be located as refrigerator bay within Store - Bulk, size
according to requirements
Store - Flammable Liquid stfl-i or similar 1 x 9
Control Office off-s9-i or similar 1 x 9
Office - single Person off-s12-i or similar 1 x 12 For Warehouse Manager
Office - 2 Persons Shared off-2p-i 1 x 12 For Purchasing Officers or Warehouse Personnel
Property Bay - Staff prop-2-i prop-6-i 2 x 2 Separate for Male & Female
Toilet - Staff (Male/ Female) wcst-i 2 x 3 Separate for Male & Female
Sampling
Material Airlock airl-6-i similar 2 x 6 second airlock optional
Gowning gw-up-i 1 x 6
Sampling Room NS 1 x 20 Comply with international clean room standards; comply to Part E -
Engineering Service
Clean Up clup-7-i or similar 1 x 7
Weighing Optional. Required if there are multiple Production Rooms within the
block
Pre-Staging NS 1 x 15
Material Airlock airl-6-i similar 2 x 6
Weighing NS 1 x 20 Size according to requirements
Clean Up clup-7-i or similar 1 x 7
Gowning gw-up-i 1 x 6
Post-Staging NS 1 x 15
Production
Gowning (Male/ Female) gw-up-i 4 x 6 Can be combined with the Airlock
Airlock (Male/ Female) airl-6-i similar 4 x 6
Material Airlock airl-6-i similar 4 x 6
Production Room NS 2 x 30 Size according to requirements
Secondary Packaging NS 2 x 20 Size according to requirements
Warehouse

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ROOM/ SPACE Standard Component 2 Production Rooms NA Remarks

Unit Size Room Codes

Loading Dock lodk-i 1 x 0 External space

Stork - Bulk stbk-40-i or similar 1 x 40 Size according to requirements
Control Office off-s9-i or similar 1 x 9
Office - Single Person off-s12-i or similar 1 x 12 For Warehouse Manager
Office - 2 Persons Shared off-2p-i 1 x 12 For Warehouse Personnel
Property Bay - Staff prop-2-i prop-6-i 2 x 2 Separate for Male & Female
Toilet - Staff (Male/ Female) wcst-i 2 x 3 Separate for Male & Female
Administration/ Support Areas
Quality Check Laboratory
Office - Single Person off-s12-i or similar 1 x 12 For Production Manager
Office - Single Person off-s9-i or similar 1 x 9 For Line Manager
Office - 2 Persons Shared off-2p-i 2 x 12
Cafeteria srm-35-i 1 x 35 Located outside of the Production building
Sub Total 629
Circulation % 30
Total Area 818

Please note the following:

▪ Rooms and areas indicated in the schedule reflect the typical arrangement. Rooms should be designed in order to suit the operations to be carried out and the
equipment planned.
▪ All the areas shown in the SOA follow the No-Gap system described elsewhere in these Guidelines.
▪ Exact requirements for room quantities and sizes will reflect Key Planning Units (KPU) identified in the Clinical Service Plan and the Operational Policies of
the Unit.
▪ Office areas are to be provided according to the number of endorsed fulltime positions in the unit.

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7 Further Reading
Planning and design should consider the following developments in Pharmaceutical Factories:
▪ https://www.pharmamanufacturing.com/production/automation-
control/article/11363373/pharmaceutical-weighing-weighing-and-dispensing-do-it-right-
pharmaceutical-manufacturing
▪ Annex 2, WHO good manufacturing practices for sterile pharmaceutical products
▪ Annex 2, Guidelines on heating, ventilation and air-conditioning systems for non-sterile
pharmaceutical products, Part 2: Interpretation of Guidelines on heating, ventilation and air-
conditioning systems for non-sterile pharmaceutical products
▪ Annex 9 Guidelines on packaging for pharmaceutical products, WHO

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