Packaging
Medical Device & Pharmaceutical Cleanroom/Aseptic Packaging Solutions
Cleanroom/Aseptic Packaging Services
Prince Sterilization Services provides comprehensive cleanroom packaging, kitting, and aseptic assembly services for the medical device, pharmaceutical, and cell and gene therapy (CGT) markets.
From finished product medical device packaging to bespoke patient kitting services catered to cell and gene therapy and CAR-T manufacturers, Prince’s FDA-registered, ISO 13485 certified, cGMP compliant manufacturing facilities ensure regulatory compliance, supply chain traceability, efficiency, and accelerated time to market.
We serve as a seamless extension of your team, with capabilities to work within your ERP/SAP systems and adhere to your operational, quality, and inventory stocking procedures, utilizing trained and experienced operators, robust systems, and a proven ability to manage complex custom projects with medical grade materials.
State-of-the-Art Cleanroom Facilities
Prince performs all contract packaging, assembly, and kitting operations within state-of-the-art ISO Class 5, 6, and 7 compliant environments built to meet the stringent cleanliness requirements of medical devices and pharmaceutical manufacturing. These controlled areas maintain ultra-low viable and nonviable particulate levels, precise environmental controls, and comply with cGMP standards.
With extensive cleanroom capacity and adjacent controlled-environment storage, Prince manages complex kitting and assembly programs across a range of product categories, ensuring quality, traceability, and speed are not compromised.
Adjacent Processing: WFI Rinsing & Terminal Sterilization
To ensure the highest levels of cleanliness and sterility assurance, Prince offers critical pre and post packaging processing services within our validated cleanroom environment and ISO quality management system:
Pre-Packaging Services
- Water for Injection (WFI) Rinsings
- Reduces endotoxins, pyrogens, and particulate matter using USP-grade Water for Injection.
- Manual Component Wiping
- Targeted surface cleaning with sterile cleanroom wipes removes process oils, debris, and contaminants—ideal for significantly reducing bioburden and particulate levels from secondary and tertiary packaging.
Post-Packaging Sterilization & Biodecontamination Options
- Vaporized Hydrogen Peroxide (VH₂O₂) Sterilization & Biodecontamination
- Moist Heat (steam) Sterilization
- Dry Heat Sterilization
By offering both pre- and post-packaging process steps, Prince delivers a single-source, cleanroom-controlled solution that minimizes handoffs, reduces contamination risk, and accelerates release timelines.
Comprehensive Packaging, Assembly, & Kitting Services
- Logistics & Supply Chain Management
- Packaging Design & Material Selection
- Validation & Testing
- Quality Control & Traceability
- Terminal Sterilization (VH₂O₂ & Steam)
By integrating packaging with final sterilization, we provide a seamless, one-stop solution – delivering kits and components that are sterile, sealed, and ready to use upon arrival.
Tailored Packaging & Kitting for Regulated Markets
Prince supports the unique requirements of the medical device, pharmaceutical, and cell and gene therapy (CGT) industries with cleanroom-based, cGMP compliant packaging and kitting solutions. Whether you're managing high-volume device programs, sterile injectables, clinical trials, or small-batch patient-specific therapies, our team brings the technical expertise and infrastructure to help you scale.
Prince provides a cleanroom environment, sterilization infrastructure, and regulatory knowledge all in house to streamline your supply chain and accelerate launch timelines.
Medical Device
- Packaging, assembly, and kitting under cleanroom conditions
- Complex device and tubing set assembly, labeling, and sterile barrier system handling
- Validation support
- Custom tray packaging, perforated pouches, and component lot tracking
Pharmaceutical
- Secondary packaging services supporting parenteral drug packaging for injectables, drug delivery systems, and Sterile Ready-to-Use (RTU) Components
- Cold chain support and ambient controlled storage
- Moist heat and Vaporized Hydrogen Peroxide (VH2O2) terminal sterilization integration
- GMP-trained operators following strict SOPs and documentation protocols
Cell and Gene Therapy (CGT)
- Material compatibility reviews and sterilization feasibility testing
- Small batch, high-touch kitting & assembly with tight traceability controls
- Bespoke patient specific kit biodecontamination and assembly under ISO Class 5, 6 and 7 environments
- Warehouse support for supply chain continuity
- Seamless integration into site specific software systems such as SAP
- Chain-of-identity support, custom labeling, and just-in-time production