Prince Sterilization Services
Contract sterilization and sterile component services provider for the pharmaceutical, medical device, and related healthcare industries. Operates FDA-registered, cGMP-compliant facilities and holds ISO 13485:2016 certification. Offers multiple terminal sterilization modalities, depyrogenation, WFI rinsing, aseptic ISO 5 packaging, RTU sterile component kits, and sterilization cycle development and validation services.
Industries
Nr. of Employees
small (1-50)
Prince Sterilization Services
Products
Ready-to-use sterile kits (vials, seals, stoppers)
Aseptically packaged kits of purified, depyrogenated or sterilized glass vials and associated closures, supplied sterile and certified for particulate and endotoxin limits.
Ready-to-use sterile kits (vials, seals, stoppers)
Aseptically packaged kits of purified, depyrogenated or sterilized glass vials and associated closures, supplied sterile and certified for particulate and endotoxin limits.
Services
Contract terminal sterilization
Contract sterilization for filled drug products, components and medical devices using steam, dry heat, and low-temperature vaporized hydrogen peroxide.
Depyrogenation and WFI rinsing services
Depyrogenation of glassware and components, WFI rinsing, and endotoxin/particulate certification in support of parenteral product manufacture.
Sterilization cycle development and validation consulting
Development, validation and documentation of sterilization cycles (F0/D/z analysis, BI usage, penetration studies) and parametric release support.
Packaging and RTU component supply
Supply of sterile ready-to-use vials, seals and stoppers individually or assembled as kits with aseptic packaging.
Contract terminal sterilization
Contract sterilization for filled drug products, components and medical devices using steam, dry heat, and low-temperature vaporized hydrogen peroxide.
Depyrogenation and WFI rinsing services
Depyrogenation of glassware and components, WFI rinsing, and endotoxin/particulate certification in support of parenteral product manufacture.
Sterilization cycle development and validation consulting
Development, validation and documentation of sterilization cycles (F0/D/z analysis, BI usage, penetration studies) and parametric release support.
Packaging and RTU component supply
Supply of sterile ready-to-use vials, seals and stoppers individually or assembled as kits with aseptic packaging.
Expertise Areas
- Contract sterilization services for pharma and medical devices
- Terminal sterilization process development and validation
- Depyrogenation and container/closure processing
- Sterile ready-to-use (RTU) component manufacturing and packaging
Key Technologies
- Moist heat steam sterilization (autoclave / AOP steam sterilizers)
- Dry heat sterilization and depyrogenation
- Low-temperature vaporized hydrogen peroxide sterilization
- Liquid chemical sterilization methods