Title: How to Start the Manufacturing of Disposable Syringes?
1HOW TO START THE MANUFACTURING OF
DISPOSABLE SYRINGES?
Presented by Operon strategist
2HOW TO START THE MANUFACTURING OF DISPOSABLE
SYRINGES?
Securing a CDSCO manufacturing license indicates
that the manufacturer has been thoroughly
evaluated and has met the established standards.
This ensures that the disposable syringes
produced are safe, effective, and of high
quality. Compliance with these regulatory
requirements is crucial not only for legal
purposes but also to guarantee the safety and
efficacy of the medical devices. This safeguards
the health of consumers and patients who will use
these products.
3DISPOSABLE SYRINGE MANUFACTURING PROCESS
- Material Unloading Process
- De-dusting of material in dedusting area
- Raw material
- U/T Raw Material
- Approved Raw material
- Manufacturing of component Barrel, Plunger and
Gasket in molding machine area - Component Cleaning
- Barrel scale printing on barrel printing machine
- Assembly of Plunger, Barrel Gasket and Needle on
automatic assembly line - Primary packing in blister packing machine in
packaging room - Box packing process in Secondary Packing Room
- Sterilization Process
- Quarantine Finish Product Area
- Approved Finish Product
- Store in Finish Product store ready
- Ready to Dispatch
4 Machinery used
- Injection molding machine
- Barrel Printing machine
- Syringe Assembly machine.
- Syringe Feeding machine.
- Blister Packaging machine,
- Ribbon Packaging machine
OTHER AUXILIARY MACHINERY
- Dryer
- Mixer
- Chiller
- Scrap grinding machine.
- QC equipments etc.
5MANUFACTURING RAW MATERIALS
- Needle (SS)
- Packing Material (Corrugated Boxes, Printing
Roll, etc.) - Printing Ink
- Silicon
- EO Gas
- Land requirements are generally decided according
to your business size, major area used for
warehouses and production, and occupancy
requirement to set up a plant - Skilled workers/Unskilled worker
- Supervisors
- Security
- Account assistant
- Marketing Executive
- QA head, QC head, Production head
- Executive officers for each department.
6The disposable syringe market has been rapidly
growing, driven by global vaccine demand,
government funding, and advancements in
self-injection devices and syringe technology.
Graphical data shows year-by-year market growth.
Disposable syringes are replacing traditional
glass ones due to their accessibility,
sterilization, readiness for use, and
cost-effectiveness. Additionally, the global AIDS
crisis has increased demand for disposable
syringes. Made from polypropylene, syringes are
available in various sizes (1 ml, 5ml, 10ml, 50
ml) and designs. The number of injection molding
machines required depends on syringe design, mold
cavities, and annual production. Operon
strategist offer one-on-one regulatory consulting
to support clients' steady growth in the medical
device industry.
7OPERON STRATEGIST
For more information about Medical Device
Regulations please feel free to contact
enquiry_at_operonstrategist.com Or Visit
https//operonstrategist.com Call Us Now
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ffice 14, 4th Floor, MSR Capital, Morwardi Road,
Pimpri Colony, Pimpri, Pune 411018