XYZ Co, Inc.

Number: WI-12345-003
Product Development Process
Revision: B
XYZ Co, Inc. – Design History File Index
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Product quality review content

First, could you set up an SOP that details the requirements of the product quality review? Templates should also be
available to assist with the completion of the report.

After the product quality review, prepare a summary report with chapters covering all critical elements of the product
life cycle.
 At a minimum, the chapters should include:

– An analysis of the production process

– A review and investigation of all deviations and non-conformances

– A review of all approved change controls that could impact product quality, validation status, or regulatory filing for
the product

– An analysis of the microbiological and chemical test results and conformance with specifications

– An analysis of stability studies and associated test results

– An assessment of component quality based on a review of the starting materials and primary packaging that comes
into direct contact with the product

– A review of market activity, concentrating on product returns, complaints and recalls

– A regulatory assessment consisting of any changes to the specifications as registered by all relevant regulatory
agencies

– An assessment of the validated or qualified status of all processing, cleaning, analytical methods, automated controls,
or packaging validation

– An assessment of relevant suppliers and currency of relevant GMP agreements

Annual product quality review should make recommendations for improvement based on the analysis.

Just to let you know, confirmation of those recommendations should be adopted as required.

Certainly! While there isn’t a one-size-fits-all template for a Device History Record (DHR), I can
provide you with a general outline that covers essential elements for syringes and needles manufacturing.
Remember to tailor this to your specific device and system. Here’s what you might include in your DHR:
1. Device Information:
o Device Identification: Unique identifiers for each syringe or needle.

o Control Numbers: Any control numbers or batch/lot identifiers.

2. Manufacturing Details:
o Dates of Manufacture: Record when each device was produced.

o Quantity Manufactured: Specify the total quantity produced.

o Quantity Released for Distribution: The number of devices approved for distribution.

o Proof/Records of Operations: Documentation that all processes described in the Device

Master Record (DMR) were completed.
3. Labeling and Packaging:
o Labeling Used: Include details about labels applied to each production unit.

o Packaging Information: How the devices were packaged for distribution.

4. Quality Assurance Records:

o Acceptance Records: Demonstrate that each device was manufactured in accordance with
the DMR.
o Final Inspection Records: QA inspection results for each device.

Remember that your DHR should be unique to your specific manufacturing process and comply with
regulatory requirements. Adapt this outline to fit your syringe and needle production process12
Five steps for the complete syringe production process
Injection Section:
Barrel and plunger are formed through mould installed in the injection machine with
hot-melt PP material injected. It is the most important part in the syringe production
process, as the design and accuracy of mould will determine the final quality of
syringe.
Barrel Printing Section:
Print the scale line and logo on the syringe barrel. A clear, indelible scale line and logo
will improve the level of the syringe.
Assembly Section:
Assemble all parts of syringe, including the plunger, gasket, barrel and needle, to form
one complete set of syringe. A stable and high-speed assembly machine will greatly
increase the daily output.
Packing Section:
The assembled syringe, as a kind of medical product, it needs individual packing to
keep clean before going out of clean room. The packing process is handled by packing
machine. There are two types of packing machine, automatic blister packing machine
and automatic ribbon packing machine. Clients can choose according to the market
demand. After individual packing, the packed syringe needs to be placed in box and
carton to complete the final packing.
Sterilization Section:
To make sure that the syringe is sterile, progeny-free, packed syringes need to be
sterilized by ethylene oxide gas before entering the market. The main equipment in
this workshop is ETO sterilizer. If clients need, a preheating system can be added to
shorten the cycle time of sterilization. And clients can also purchase a residual gas
treatment system to meet higher requirement of environment control.
QUALITY CONTROL IN SYRINGE PRODUCTION
Home Quality Control in Syringe Production
Syringes are fundamental tools in modern healthcare, serving essential functions such as drug administration
and blood sampling. Their indispensability makes it imperative that every syringe adhere to the highest safety
and efficiency standards. Quality control in syringe production is thus paramount, ensuring not only patient
safety but also the effectiveness of medical treatments. Additionally, stringent quality checks are imperative to
comply with regulatory standards.

This blog explores the intricate manufacturing process of syringes, which involves rigorous quality control
measures that uphold their reliability and safety.

HOW ARE SYRINGES MANUFACTURED?

Syringe manufacturing is a detailed process that begins with selecting high-quality, medical-grade materials.
These materials, often plastics, are chosen for their durability, sterility, and compatibility with medical use.
The production process involves precision moulding to form the barrel, plunger, and other components,
ensuring each part meets exact size and shape specifications for optimal performance.

In the subsequent stages, these components are assembled in sterile environments to prevent contamination.
The syringes are then equipped with needles, if necessary, and undergo a series of sterilization procedures.
Throughout this process, adherence to industry safety and regulatory standards is paramount, ensuring
each syringe produced is reliable and safe for medical applications.

QUALITY CONTROL MEASURES

This involves a series of stringent checks and measures at each stage of production, adhering to the highest
industry standards.

1. Raw Material Inspection: The quality check begins with thoroughly inspecting raw materials, ensuring
they meet predefined standards for sterility and safety.
2. Dimensional Accuracy Checks: During production, syringes are checked for dimensional accuracy to
match the specified sizes and volumes.
3. Sterility Testing: Post-manufacturing, syringes undergo rigorous sterility tests to ensure they are free from
microbial contamination.
4. Functional Testing: This includes testing the plunger movement’s smoothness and the syringe barrel’s
integrity.
5. Leak Test: Each syringe is tested for leaks to ensure it can hold and administer medication effectively.
6. Visual Inspection: Syringes are visually inspected for defects, such as cracks or misaligned parts.
7. Needle Sharpness Test: For syringes with needles, the sharpness and durability of the needle are tested to
ensure efficient and pain-free penetration.
8. Lot Sampling: Random samples from production lots are tested to ensure consistency and adherence to
quality standards across batches.
9. Packaging Integrity Check: The final product is checked for packaging integrity, ensuring it remains
sterile and undamaged during transit and storage.
10. Regulatory Compliance: Regular audits and checks are conducted to ensure compliance with local and
international regulatory standards, including the Food and Drug Administration (FDA).
These tests need not to be performed manually but some defects are also controlled by the automatic machine
itself through vision inspection cameras. The quality inspection system acts as a double check to control
product performance across high levels of mass manufacturing which is upheld as top regard by HMD.

CONCLUSION
The stringent quality checks and measures in syringe production are safeguards that ensure the highest
standards of safety and efficacy. Regulatory compliance requirements guarantee that these standards are
consistently met and upheld.

At HMD, we are committed to excellence. Each HMD syringe undergoes exhaustive quality control, ensuring
it meets and surpasses the requisite quality and safety benchmarks. This dedication to rigorous testing means
HMD syringes are designed for the utmost patient safety and care.

Syringe

The production of syringes involves a meticulous manufacturing process and stringent quality control
measures to ensure the safe and reliable administration of medications. From the initial stages of material
selection and moulding to the final assembly and packaging, every step in the journey of a syringe plays a
critical role in maintaining its quality and functionality. In this blog, we will take a detailed look at the
manufacturing process of syringes, exploring the various steps involved and the importance of quality
control at each stage.

1. Design and Material Selection

The initial stage in the manufacturing of syringes involves meticulous design considerations. Factors like
size, volume, needle compatibility, and user-friendliness are carefully evaluated. After finalizing the
design, the next crucial step is the selection of suitable materials. Karkhana.io’s extensive network of
certified suppliers guarantees the procurement of premium-quality materials that meet rigorous safety and
regulatory standards set by the industry.

2. Injection Moulding

Injection moulding is a widely employed manufacturing process for syringes, wherein molten plastic is
injected into a mold cavity, imparting the syringe with its desired shape. This method facilitates efficient
mass production of syringes while maintaining consistent dimensions and high accuracy. Karkhana.io’s
proficiency in injection molding guarantees the creation of syringes with meticulous tolerances and
impeccably smooth surfaces.

3. Assembly and Packaging

After the syringe barrels and plungers are molded, the assembly process begins. The plungers are inserted
into the barrels, and the syringes are carefully inspected for any defects or imperfections. Once
assembled, the syringes undergo thorough quality control checks. They are then sterilized and packaged
to maintain their integrity until they reach the end-user. Karkhana.io’s commitment to quality ensures that
each syringe undergoes rigorous inspection and adheres to the highest industry standards.

4. Quality Control Measures

Ensuring the safety and reliability of syringes is of paramount importance. Karkhana.io implements
stringent quality control measures at every stage of the manufacturing process. This includes visual
inspections, dimensional measurements, functional tests, and sterilization validation. By following these
measures, Karkhana.io guarantees that every syringe meets the necessary specifications and is free from
defects.

5. Regulatory Compliance

The medical devices industry is highly regulated, and syringes are no exception. Karkhana.io is well-
versed in the regulatory requirements and standards governing the manufacturing of medical devices.
They ensure that their manufacturing processes and quality control measures align with the relevant
regulatory guidelines. This commitment to compliance assures customers that Karkhana.io’s syringes are
safe, reliable, and meet all necessary regulatory requirements.

Conclusion

The manufacturing journey of a syringe involves meticulous design, precise injection molding, rigorous
quality control measures, and adherence to regulatory standards. Our expertise in manufacturing solutions
enables us to deliver high-quality syringes that meet the specific needs of the medical devices industry.
With the commitment to excellence and a wide network of certified suppliers, Karkhana.io is well-
positioned to cater to the demands of the medical devices sector.

To learn more about Karkhana.io’s capabilities in syringe manufacturing and explore their range of
manufacturing solutions, visit our website and fill out the contact form. Our team of experts is ready to
assist you in achieving your manufacturing goals.

Fill out the form to partner with Karkhana.io for your syringe manufacturing needs in the medical
devices industry.
Disposable Syringe Manufacturing Process and Machineries
By Operon Strategist / August 31, 2019

Disposable Syringe Manufacturing License

The CDSCO (Central Drugs Standard Control Organization) serves as the regulatory authority
overseeing pharmaceuticals and medical devices in India. Manufacturers of medical devices, such
as disposable syringes, must obtain a manufacturing license from the CDSCO to legally produce
these items within the country.

Securing a CDSCO manufacturing license is a compulsory regulatory step for the production of
disposable syringes in India. This license ensures that manufacturers adhere to required quality
standards, safety regulations, and guidelines mandated by the CDSCO. The licensing process
entails a comprehensive assessment of the manufacturing facility, procedures, quality control
protocols, and adherence to Good Manufacturing Practices (GMP) as outlined by regulatory
authorities.

Needle and Disposable Syringe Manufacturing Line Process Guidance

Many manufacturers struggle with the initiation process, they do want to set up the plant and move
forward but they are behind due to adequate knowledge. We can resolve their doubts about
disposable syringes by guiding the plant layout design, clean room design, product feasibility, and
regulatory aspects. Disposable devices are notified devices and they need the CDSCO
manufacturing license. As per the latest notification of CDSCO, the manufacturer who fails to
register their device may face action against them. To avoid this action you can speed up
the CDSCO registration process with our team.

With extensive technical experience, Operon Strategist is the best consulting company for syringe
manufacturers in India.

Looking for Disposable Syringe Manufacturing Process Consultant?

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Disposable Syringe Manufacturing Process

A Disposable syringe is a basic responding siphon comprising of a plunger (however in present-day
syringes, it is a cylinder) that fits firmly inside a round and hollow cylinder called a barrel. For
syringe manufacturing plunger can be directly pulled and pushed along within the cylinder, enabling
the syringe to take in and oust fluid or gas through a release hole at the front (open) part of the
bargain.

The open part of the bargain might be fitted with a hypodermic needle, a spout, or tubing to
coordinate the stream into and out of the barrel. Syringes are as often as possible utilized in clinical
medication to control infusions, imbue intravenous treatment into the circulatory system, apply
mixes, for example, paste or oil, and draw/measure fluids.

Firstly all the disposable syringes & needle production line is manufactured with the use of
Polypropylene. You have to decide on which type of sizes you want to make. The normal standard
charges are 1ml, 2ml, 5ml and 10ml. because of health awareness and health consciousness, you
can get a lot of profit from the needle and disposable syringe manufacturing business.
Initially, glass dominated the production lines for syringes and needles. However, disposable
syringes are swiftly gaining traction due to their convenience, sanitary conditions, and cost-
effectiveness. The global emergence of AIDS and other fatal diseases has underscored the
importance of avoiding syringe reuse, leading to a substantial surge in demand for disposable
alternatives.

For More Details About Disposable Syringes Manufacturing

CONTACT US

Machinery Used for Needles and Disposable Syringe Manufacturing:

 Sterilization Plant
 Blister Packaging machinen
 Automatic packaging machine
 Scrap Guiding machine
 Zigma injection molding machine
 Weighing scale
 Water Pump
 Air Compressor
 Chilling Plant
 Testing Equipment
  Electrical Fittings & Socket
 Set of molds for barrels
 Set of molds for syringes body 16 cavities for barrel & 16 cavity for plungers.
Raw Materials Used for Needles and Disposable Syringe Manufacturing and Other
Requirements
There are generally two types of raw materials, required to manufacture syringes. The first thing is
polypropylene and the other is the needle. Land requirement is generally decided according to your
business size.

Raw materials which are used in this business

1. Polypropylene
2. Ethylene Oxide
3. Packing paper
4. Rubber gaskets
5. Needles
6. Printing Ink
Required Manpower:

If you are planning to start an average size business of syringe manufacturing things you may need
for your plant

1. Skilled workers/Unskilled workers

2. Supervisors
3. Security
4. Account assistant
5. Marketing executive
What Type of Machinery will Require for a Disposable Syringe Manufacturing Business?
For factory design or unite design of disposable syringe you will require following machinery :

 Injection Molding Machine

An injection molding machine also known as an injection press is a kind of machine used for
manufacturing plastic products with the Injection molding production. Types of injection molding
machines,

Mechanical

This type of machine is used to toggle the system for building up the tonnage on the side of the
machine, that does not open due to injection pressure.

Hydraulic

These machines are not that nearly precise, and are the predominant type in most of the world.

Electric

The electric press also known as electric machine technology, reduces the cost by cutting the
consumption of energy. Electric press is said to be quieter, faster, and have the highest accuracy.
 Also, Read – Why follow safe injection syringes & standards?

 Screen printing machine

After the completion of the first step, the next thing is to print the injections appropriate to their
standard level marking. You have to make sure about the alternative machine for manufacturing
companies for price variation.

 Sterilization plant
For the sterilization process, they have to use ethylene oxide. Ethylene oxide (ETO) is known as the
gas used for low-temperature sterilization. It is generally used to sterilize instruments or devices and
all those products that have to be sterilized but cannot stand high temperatures.

 Syringe packing machine

The syringe packing machine is used for the automatic syringe mass packing. For this, you have to
check all types of machine sizes and prices at every different industrial machine store.

 Syringe assembly machine

For the syringe Assembly machine, a hopper and a bowl feed the syringe plungers with the help of
an inline track to a dead track where they are picked and placed 2 up into a double nest onto a 24
position on an indexed dial plate. In the Disposable Syringe assembly machine hopper and bowl
feed needle-in-hubs and 2 up places needles on barrels.

Also read, Top 5 Syringe Making Machine Manufacturers

You can always choose Operon Strategist medical device consultancy which provides cost-effective
regulatory services for timely results. Read the blog here about How to Manufacture Disposable
Syringe. We also provide CE certification consultation in Saudi Arabia, the USA, and Egypt.

Is syringe manufacturing profitable?

Manufacturers of syringes and needles - two basic items in any medical setup - enjoy a whopping
trade margin ranging from 250-1,250%, according to a new analysis by the National Pharmaceutical
Pricing Authority (NPPA).

What are disposable syringes made of?

Disposable Syringe Body and plunger are made from polypropylene, seal on plunger is made from
polyisoprene (rubber).

How is a syringe produced?

A three-part syringe contains a plastic plunger/piston with a rubber tip to create a seal between the
piston and the barrel, where a two-part syringe is manufactured to create a perfect fit between the
plastic plunger and the barrel to create the seal without the need for a separate synthetic rubber
piston.

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