Infrastructure
Our infrastructure is your key to manufacturing a high-quality healthcare device, from original concept to commercialization

Providing you with the latest facilities, equipment and practices
Partner with SteriPack and unlock cutting-edge physical and digital technologies in our global network of medical device and pharmaceutical grade facilities. This includes cleanrooms, cold chain storage, design and product development hubs and even our own microbiology testing lab.

See us as an extension of your own operations
We believe in investing in your needs on a project-by-project basis, dedicating cleanroom space and tailoring specialist technologies to meet your unique requirements. In this way, our facilities feel like your own.
We are strategically located across the globe to support you in your market and beyond. Every site meets the same SteriPack benchmark with the latest standardized global business systems and processes, giving you confidence in quality and compliance continuity wherever you or your customers are based.

ISO Class 7 and 8, Grade B C & D Cleanrooms
Our global facilities have a range of high-level cleanrooms for the complex components in your medical device or pharmaceutical innovation, adhering to all relevant standards.
- ISO class 7 and 8 cleanrooms
- Grade B, C and D cleanrooms
- Gray and black zones for secondary and tertiary packing
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Injection molding, welding and overprinting
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Packaging sterilization and aggregation
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Sterile barrier packing
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Clean pack & sterilize for orthopedic and pharmaceutical components
Cold chain storage
Your drug products are in safe hands in our temperature-controlled cold chain storage facilities. We continually monitor cold chain storage temperature through data loggers so that they remain within the required range. Time Out of Refrigeration (TOR) is kept to required limits, which we control using PasX – a best-in-class MES system.
We have the capacity to meet your current storage requirements and a forward-thinking approach to scaling for additional storage, so our capacity grows with you.

High-purity RO water
For the cleaning and rinsing of orthopedic devices and primary pharmaceutical device components, Water for Injection (WFI) is needed in large quantities at a very specific quality level. At our facilities, we use Reverse Osmosis (RO) and distillation processes to generate highly purified water on-site to ensure a reliable and consistent supply.

Microbiology laboratory
To provide assurance that our manufacturing facilities and processes meet your stringent requirements, we have a dedicated in-house laboratory which is ISO 17025 accredited and provides the following test services:
- Sterile barrier system testing for dye penetration, seal strength, bubble leak, aging and transportation
- Sterility testing Bioburden testing
- LAL tests for bacterial endotoxins
- Cleanroom testing for air, surfaces and personnel
- Particulate / cleanliness testing for ready-to-use (RTU) pharmaceutical primary packaging components
- 2D and 3D dimensional control (internal and external), tensile and torque

Digital infrastructure
Our digital infrastructure is just as cutting-edge as our physical infrastructure, with interconnected systems for right-first-time product delivery. Our fully trained teams keep manufacturing efficiency, batch record accuracy, product traceability and maximum agility in highly complex manufacturing environments. So you can relax knowing rigorous controls are in place to guarantee product quality and reliable and repeatable manufacturing performance long term.
Our key digital systems:
- Enterprise & Resource Planning (ERP) for production planning, stock and cost management
- Manufacturing Execution Systems (MES) for product release and electronic batch records
- EDMS and QMS for documentation management, training and quality modules
- Computerized Maintenance Management System (CMMS)
- Smart Factory Production Management System for integrated process data for productivity reporting and long-term continuous improvement

Design & product development facilities
Our UK and US design and product development facilities offer you an all-in-one-hub to push your product innovation to exciting new places. We manage all elements of design, prototyping, testing, and engineering using a huge range of methods from 3D printing to CNC to vacuum casting on-site. We even offer in-house research viewing facilities so that you can watch and learn from users live.
Our testing laboratories are ISO 13485 and ISO 9001 certified to undertake mechanical testing and measurement, metrology, tensile testing of materials, accelerated aging, and environmental testing.

An all-under-one-roof approach to manufacturing
Our reliable and compliant infrastructure supports a wide range of services you could need, from innovative design through to complex assembly, kitting, sterilization management and final packing.
⋮ Support Services
Find out how we support your design, manufacturing and packing needs with a comprehensive range of support services. We have global experts in everything from supply chain management, project management, quality and infrastructure – ready to provide guidance and ease your journey to market.
Partner with a leading global CDMO
By opting to partner with us, you can trust in advanced manufacturing technologies and total expertise, so that your healthcare product reaches market with speed and efficacy.