(Download: Cleaning & Reprocessing in PDF by Medistri)
In regulated manufacturing environments, cleaning and reprocessing play a critical role in ensuring that materials and products can safely and consistently progress through downstream operations. These activities directly support product quality, process reliability, and regulatory compliance across a wide range of healthcare manufacturing services.
At Medistri, cleaning and reprocessing are integrated within our Manufacturing Services as part of a structured and controlled workflow, supporting components, sub-assemblies, kits, and finished products throughout their manufacturing lifecycle.
Defined Upstream Evaluation
Materials received into the manufacturing department may originate from different suppliers, processing stages, or transport conditions. As a result, their initial state can vary significantly. Rather than applying systematic cleaning or disinfection, Medistri follows a defined evaluation phase to determine the appropriate approach. This assessment may include documentation review, visual inspection, and laboratory analyses such as bioburden testing.
The outcome of this evaluation defines whether cleaning, reprocessing, or controlled handling is required before further manufacturing activities. This data-driven approach ensures that each processing step is technically justified and aligned with product requirements.
Seamless Transition to Manufacturing Operations
Cleaning and reprocessing are closely connected to downstream manufacturing activities. Once materials are released by the Quality team, they transition into assembly, packaging, or preparation for sterilization according to defined workflows.
By integrating cleaning, reprocessing, assembly, packaging, and sterilization readiness within a single operational framework, Medistri ensures continuity across manufacturing steps while reducing interfaces and operational complexity.
Quality Oversight and Documentation
All cleaning and reprocessing activities are embedded within Medistri’s quality management system. Procedures, records, and release criteria are defined to support internal controls, audits, and regulatory inspections. This structured framework provides clear visibility on process execution and decision-making, ensuring that manufacturing activities remain controlled and compliant at every stage.
Controlled Cleaning & Reprocessing Activities
When required, cleaning and reprocessing activities are performed according to established procedures adapted to the product configuration, materials, and regulatory context. These activities are designed to control particulate, microbial, or chemical contamination while preserving product integrity.
Operations are carried out under quality oversight and, where applicable, within controlled environments. All activities are documented to ensure traceability, consistency, and repeatability across batches.
Supporting Development and Routine Manufacturing
From early development activities to routine manufacturing operations, Medistri adapts cleaning and reproc essing strategies to product maturity and process complexity. As manufacturing processes evolve, approaches can be refined and validated to ensure long-term robustness and alignment with regulatory expectations.
To learn more about Medistri’s Manufacturing Services, please visit our website here or contact our team at contact@medistri.com.
— The Medistri Team
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Medistri’s Solutions for Products in Pre-Clinical Phase
During the pre-clinical phase, execution is essential to validate concepts, generate reliable data, and establish a strong foundation for regulatory approval.
Medistri serves as your integrated infrastructure partner, delivering a comprehensive portfolio of in-house Solutions optimized for R&D and proof-of-concept development.
Our solutions encompass R&D treatment cycles (custom sterilisation protocols), cleaning & reprocessing, product assembly, and packaging, alongside specialized testing including biocompatibility, extractables & leachables, sterile barrier integrity, environmental conditioning, laboratory analysis development, batch release, and regulatory consulting.
This vertically integrated model minimises vendor coordination, expedites development iterations, guarantees data integrity and compliance from inception, and enables your team to prioritise core scientific and engineering advancements.
Positioning you for seamless progression to clinical trials and commercialization.
Medistri is Europe's leading independent contract sterilisation company, founded in 2006 and headquartered in the heart of Switzerland. We are a global player providing essential infrastructure that powers healthcare innovation worldwide.
We serve customers of all sizes, from startups, university projects, and research institutes to Fortune 500 corporations, across Medical Devices, Pharmaceutical Packaging, and Biotech.
Medistri supports products at every stage of the lifecycle: pre-clinical development, go-to-market, and full industrialization.
Our fully integrated, end-to-end in-house solution allows our customers to focus on what matters most: engineering, innovation, and development, while we manage the critical backend processes.
Our synchronized departments work together to provide a complete stack of services:
- Contract Sterilisation & Validation Services
- Contract Laboratory Services
- Contract Manufacturing Services
- Logistics Services
- Consulting Services
We help you accelerate time-to-market, reduce barriers to scale, and deliver safer, more sustainable healthcare solutions to patients around the world.
Frequently Asked Questions
1. What is the role of cleaning and reprocessing in regulated manufacturing environments?
- Cleaning and reprocessing ensure that materials and products can safely move through downstream manufacturing steps without introducing contamination risks. These activities support product quality, process consistency, and regulatory compliance across manufacturing operations.
2. Why is an initial evaluation performed before cleaning or reprocessing?
- Incoming materials may arrive in different conditions depending on suppliers, prior processing, or transport. An initial evaluation determines whether cleaning, reprocessing, or controlled handling is required, ensuring that actions taken are technically justified and appropriate for the product.
3. How are cleaning and reprocessing activities controlled during manufacturing
- When required, cleaning and reprocessing are performed using established procedures adapted to material type, product configuration, and regulatory context. Activities are carried out under quality oversight and documented to ensure traceability, repeatability, and consistency.
4. When do cleaned or reprocessed materials transition to downstream operations
- Materials move to assembly, packaging, or sterilization preparation only after release by the Quality team. This controlled transition ensures that downstream operations begin with materials in a defined and compliant state.
5. How does Medistri integrate cleaning and reprocessing within its manufacturing services?
- Medistri embeds cleaning and reprocessing within a unified manufacturing framework that includes quality oversight, documentation, and laboratory support when needed. This integrated approach reduces operational complexity while maintaining control, compliance, and continuity across the manufacturing lifecycle.