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
45 Route 46 East, Suite 602, Pine Brook, NJ 07058
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 sterilization for filled drug products, components and medical devices using steam, dry heat, and low-temperature vaporized hydrogen peroxide.
Depyrogenation of glassware and components, WFI rinsing, and endotoxin/particulate certification in support of parenteral product manufacture.
Development, validation and documentation of sterilization cycles (F0/D/z analysis, BI usage, penetration studies) and parametric release support.
Supply of sterile ready-to-use vials, seals and stoppers individually or assembled as kits with aseptic packaging.
Contract sterilization for filled drug products, components and medical devices using steam, dry heat, and low-temperature vaporized hydrogen peroxide.
Depyrogenation of glassware and components, WFI rinsing, and endotoxin/particulate certification in support of parenteral product manufacture.
Development, validation and documentation of sterilization cycles (F0/D/z analysis, BI usage, penetration studies) and parametric release support.
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
News & Updates
Announcement of added in-house low-temperature vaporized hydrogen peroxide sterilization capability and expansion of modalities offered.
Technical article discussing parametric release, regulatory standards, and release strategies based on validated sterilization processes.
Technical discussion of biological indicators, D- and z-values, thermal resistance and thermal death-time curves used to develop sterilization parameters.
Award presented by NJMEP recognizing manufacturing excellence for the small business category.
Recognition by Medtech Business Review as Contract Sterilization Service Company of the Year 2024.
Announcement of added in-house low-temperature vaporized hydrogen peroxide sterilization capability and expansion of modalities offered.
Technical article discussing parametric release, regulatory standards, and release strategies based on validated sterilization processes.
Technical discussion of biological indicators, D- and z-values, thermal resistance and thermal death-time curves used to develop sterilization parameters.
Award presented by NJMEP recognizing manufacturing excellence for the small business category.
Recognition by Medtech Business Review as Contract Sterilization Service Company of the Year 2024.