Contract Manufacturing
Medical Device Contract Manufacturing
At Sterile World Technologies LLP, we perform certain level of contract manufacturing in the sterile / non-sterile packaging of medical devices.
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PRODUCT DEVELOPMENT
- Product design and development
- Regulatory affairs documentation support
- Sourcing raw materials and Quality assurance arrangements
- Lab scale production and process designing & execution
- Validation and verification testing
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ASSEMBLY
- Customized assembly line as per the FDA guidelines and customer requirement
- Product specific cleaning, disinfection, assembly and inspection process.
- Required documentation of all assembling & inspection process.
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PACKAGING
- Customized and product specific primary packaging material like Flat / Gusseted pouches/ Blister Tray/ Header Bag etc.
- Secondary pre-printed, inner carton (duplex) and outer carton (cardboard) for final packaging.
- One stop final packaging solution in the humidity-controlled environment.
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STERILIZATION
- In house ETO sterilization services on contract basis.
- Collaboration for contract Gamma sterilization.
- Consultation on required product & process validations.