Cleaning, packing and sterilization management for medical devices
Best-in-class cleanroom and sterilization management services for your ready-to-use sterile medical devices, implants, surgical instruments, pharmaceutical components and co-packed products.
Protecting patient safety
Our cleanroom cleaning, packing, labeling, and sterilization management services support implants, surgical instruments, medical devices and components intended for immediate sterile use or direct patient contact.
We manage the entire workflow, from incoming inspection and rinsing through to sterile barrier packing, labeling, boxing and sterilization management, to ensure your product meets all applicable global compliance standards and is ready for safe use.
The regulatory and quality standards we follow
We apply globally recognized quality standards across every stage of cleaning, sterile packing, labeling and sterilization management, ensuring your product consistently meets regulatory expectations and performs safely at the point of use, including sterile presentation in the Operating Room (OR) or Ambulatory Surgery Center (ASC).
Ensera’s cleanroom and sterilization management services are tailored to meet ISO 13485 and GMP Annex-1 driven requirements when product sterility and patient safety are essential. This includes orthopedic implants, instruments and single-use medical devices, surgical devices, pharmaceutical components and procedure kits.
Our four-step clean, pack and sterilize process
Cleanroom rinsing, packing, labeling and sterilization are critical steps for the safe usage, storage and transportation of ready-to-use sterile medical devices. This means you can trust in the required levels of sterility from when your product leaves our temperature-controlled cleanrooms, to when a healthcare professional uses it for the first time.
Meeting regulatory requirements with comprehensive incoming, in-process and release inspections
Before the cleaning, packing, labeling, and sterilization management process for a device commences, all relevant cleanroom processes are developed, tested and validated with the support of our seal integrity laboratory team. Some Validation standards we utilize include:
- Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection – ASTM F1886
- Standard Test Method for Linear Measurement Using Precision Steel Rule – ASTM F2203
- Aseptic processing of health care products – ISO 13408-1:2023
- Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration – ASTM F1929
- Standard Test Method for Seal Strength of Flexible Barrier Materials – ASTM F88
- Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) – ASTM F2096
- ISO 17025 – General requirements for the competence of testing and calibration laboratories
All components entering our cleanroom facilities are subject to careful incoming inspection to ensure they meet your required specifications and are free of defects, damage or unspecified contamination prior to processing.
During manufacturing and packing processes, our in-process and release quality controls measure performance and confirm its compliance to all applicable, agreed specifications and pFMEA risk mitigation controls.
Cleaning that is individually matched or adjusted to your healthcare product
At the cleaning and rinsing phase, we remove contaminants and bioburden, including through ultrasonic cleaning, to ensure your product meets the required cleanliness level before packing and sterilization. We advise on, develop and deploy a variety of cleaning and rinsing cycles to match your device-specific requirements, undertaken in Class 7 and 8 (or B, C and D) cleanrooms. Any Purified Water or Water for Injection used in our processes is supplied by in-house purification systems to ensure complete control of water quality.
Choose high quality sterile barrier protection
Device manufacturers increasingly view sterile packaging as a strategic component of device performance, moving beyond a basic protective barrier to a system that enhances safety, usability, effectiveness, supports safe handling, strengthens user confidence and reinforces brand presence.
At Ensera, we share this view. We are a trusted partner in sterile barrier system packing, protecting your device through sterilization management, transport, and use. Our experts can design or recommend Standard, Standard-plus, and Custom sterile packaging systems to match your performance needs and budget. This includes the design of innovative packaging solutions undertaken by our award-winning team at Ensera Design. With the right sterile barrier solution, your device is not only protected but also supports a smooth, consistent user experience in the OR or ASC.
Following sterile packing, labeling services controlled by our Manufacturing Execution System (MES) ensure accurate product identification and full traceability.
Benefit from 20+ years of sterilization management experience
Leading global organizations choose us to manage the gamma, x-ray, e-beam, EO, and steam sterilization of millions of medical components each year as part of our cleaning, packing and labeling process. Our long-standing relationships with approved sterilization partners, along with our in-house capabilities, give us deep knowledge of suitable sterilization methods, compatible packaging materials and associated testing and validation requirements.
Case studies
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Case study
Supporting ultra‑low‑volume orphan drug launches with complex secondary packaging
Discover how Ensera provided an orphan drug customer with flexible secondary packaging, labeling, and kitting for highly specialized injectable products in very low volumes.
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Case study
Next-generation vascular closure device: from design transfer to repeatable, scalable commercial production
Discover how Ensera accelerated technical transfer and scalable manufacturing for a next‑generation vascular closure platform in minimally invasive surgery.
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Case study
Enabling smooth, dual-market delivery of a kitted PFS biosimilar requiring terminal sterilization
When a global biosimilar company needed a flexible final assembly, kitting and packing partner with proven sterilization expertise, they came to Ensera. We were able to provide agile capacity, sterile packaging advice, and sterilization management to support a smooth and timely launch in Europe, while preparing the program for future expansion into North America.
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Our clean, pack, and sterilization management processes work alongside our wider capabilities for your sector
Whether you are launching a new product or managing a mature line, our clean, pack, and sterilization management services work alongside our wider sector capabilities to ensure your medical device, orthopedic implant or instrument, or pharmaceutical component is cleaned, packed, and processed through sterilization with approved partners, ready for healthcare professionals and patients.
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Orthopedics
Flexible and fast end-of-line and under-one-roof services for intricate, ready-sterile devices for use across diverse healthcare settings.
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Pharmaceutical services
We are partners to leading pharmaceutical organizations for the final assembly, kitting and secondary packing of combination products and other pharmaceutical solutions.
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Surgical Devices
Precision engineering and manufacturing of complex devices and surgical sets for advanced, minimally-invasive procedures.
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