Thanks to visit codestin.com
Credit goes to www.scribd.com

Scribd
Upload
11 views1 page

USFDA

The document outlines the design and operational requirements for an OSD facility to comply with PICS/USFDA standards, detailing specifications for tablet and capsule departments, civil requirements, modular needs, HVAC systems, and machine requirements. It emphasizes the need for adequate space, modular construction, and specific machinery, along with a dedicated Quality Control and Assurance Department. Additionally, it highlights the importance of a robust water system and continuous operation of HVAC units.

Uploaded by

Sherlock Sinha Chaudhuri
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
11 views1 page

USFDA

The document outlines the design and operational requirements for an OSD facility to comply with PICS/USFDA standards, detailing specifications for tablet and capsule departments, civil requirements, modular needs, HVAC systems, and machine requirements. It emphasizes the need for adequate space, modular construction, and specific machinery, along with a dedicated Quality Control and Assurance Department. Additionally, it highlights the importance of a robust water system and continuous operation of HVAC units.

Uploaded by

Sherlock Sinha Chaudhuri
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 1

Some points regarding OSD facility to comply with PICS / USFDA standards

A. Design consideration
1. Tablet Department
a. Tablet output of 10.0 – 12.0 lakhs per day / shift.
b. Facility of both Alu/ALU , ALU/PVDC and Strip packing
2. Capsule Department
a. Output of 8.0 -10.0 lakh per day / shift
b. Facility of both ALU/ALU and Strip packing.
B. Requirements
CIVIL REQUIREMENTS
1. Working floor should be approximately 17 to 18 feet clear height i.e. Bottom of beam to floor
2. There should be walkable modular false ceiling as servicing lines are inspectorate areas as per
PICS / USFDA
3. There should be a service floor between two floors to save ducting and other costs and have
organized utility area.
4. Approximately 18,000 – 20,000 sq feet required.
For your present building of 65 x 90 feet (5,800 sq feet) , it would need 3 working floors with 2
or 3 service floors.
Ground Floor – RM Store , PM Store , FG store
First Floor – Capsule Department , Secondary packing for Both tablets and Capsules and QA
with office
Second Floor – Tablet Department – Manufacturing and Primary packing
5. Minimum 2 lifts required for material movement and 1 lift for man movement.

MODULAR REQUIREMENTS and COSTING


1. Approximately 52,000 sq feet of Modular is required. Cost per sq feet @ 580 per = 3.01 crore –
3.5 crore

HVAC
1. Total 28 – 30 AHU is required @ 7,80,000 per AHU = 2.34 crore
Cost of Cooling Tower + Chiller for 100 / 125 TR = 0.62 crore
Cost of Ducting = 0.50 crore
BMS + SCADA + Software = 0 .48 crore
TOTAL 3.94 crore – 4.5 crore
AHU should be kept running 24 X 7

MACHINE REQUIREMENTS

1. Machines like Bin Washers has to be installed.


2. RMG / FBD / FBP/ Auto Coaters should hve CIP / SIP system with data loggers

Some other Notes


This block should have a complete separate Quality Control and Quality Assurance Department.
Water system with RO + EDI with water in circulation at minimum 65 deg C. All the water lines
should have boroscopy reports.

You might also like