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.

    • 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
    • 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.
    • 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.
    • In house ETO sterilization services on contract basis.
    • Collaboration for contract Gamma sterilization.
    • Consultation on required product & process validations.