Pharmaceutical and Medical Device Sterilization Experts
Prince Sterilization Services, LLC is a contract sterilization services provider that specializes in moist heat steam, low temperature vaporized hydrogen peroxide, pre-filled syringe, and dry heat sterilization and depyrogenation services. At Prince you will find a full suite of sterilization related support for pharmaceutical and medical device products including development/feasibility/engineering, validation, and routine/commercial processing cycles. Our expert staff is ready to provide case-by-case consultation support when needed. Click here to download a brochure or continue reading below to learn more about our products and services.
Moist Heat Steam Sterilization
It is a regulatory requirement that drug products that can withstand terminal sterilization be terminally sterilized. Steam sterilization is the method of choice. Prince offers full product support. Development/Feasibility, Engineering, Validation, and Commercial. Terminal sterilization of drug products, medical devices, and pharmaceutical mfg equipment including liquids in sealed vessels (pre-filled syringes, vials, IV bags, blow-fill-seal containers, sterile filling components and equipment and much more).
Contact a Prince representative to better understand how we can support your contract terminal moist heat steam sterilization needs.
Low Temperature Vaporized Hydrogen Peroxide Sterilization
Vaporized Hydrogen Peroxide is an eco-friendly and non-toxic low temperature sterilization method compatible with a broad spectrum of materials and medical devices. Hydrogen peroxide has excellent antimicrobial properties against a wide range of microorganisms, including bacterial spores. If you have a medical device or pharmaceutical component that needs to be sterile, vaporized hydrogen peroxide is an excellent choice. Prince can support the manufacturing of your sterile device from packaging through full sterilization support including development and engineering, validation and commercial release. Prince is FDA registered for drug products and medical devices and holds an ISO 13485 certification. Contact us to speak with an expert.
Contact a Prince representative to better understand how we can support your low temperature sterilization, vaporized hydrogen peroxide sterilization, and medical device sterilization needs.
Dry Heat Sterilization and Depyrogenation
Dry heat sterilization is an excellent option for components that are thermostable but sensitive to moisture. Stainless steel components such as stopper bowls and other aseptic processing equipment as well as thermostable polymers are good candidates for dry heat sterilization. Dry heat is the preferred method for depyrogenation. Glass vials, bottles, syringes, and other components that require a depyrogenation claim should be depyrogenated by heat. Prince has several dry heat ovens for batch processing as well as a dry heat tunnel for continuous washing, sterilization, and depyrogenation of pharmaceutical vials.
Contact a Prince representative to better understand how we can support your contract dry heat sterilization and/or depyrogenation needs.
Water for injection (WFI) rinsing
Water for Injection (WFI) rinsing is a fundamental process within the pharmaceutical manufacturing space, integral to ensuring the purity and safety of pharmaceutical products.
WFI rinsing serves as a critical step in cleaning and decontaminating pharmaceutical equipment, containers, and surfaces. By rinsing with WFI, manufacturers can effectively remove residues, particulate matter, and microbial contaminants, minimizing the risk of cross-contamination and ensuring product purity.
Specialized equipment and facilities that undergo routine quality control testing, monitoring, and calibration are required to produce this type of water.
Drug or medical device contact containers/devices such as syringe barrels, plungers, stoppers, seals, vials, bottles, process connectors, etc. often require WFI rinsing prior to their subsequent use downstream of the manufacturing process. Prince can support the WFI rinse, sterilization, and packaging of your product or device.