(Download: R&D Treatment Cycles for Pre-Clinical Sterilization in PDF by Medistri)
Sterilization requirements should be considered early in the development of medical devices and pharmaceutical products. Materials, product design, packaging configuration and process conditions can influence the suitability of a sterilization method and the subsequent validation strategy.
R&D Treatment Cycles provide a controlled approach to evaluate these parameters during the pre-clinical phase, before progressing to formal sterilization validation.
At Medistri, R&D Treatment Cycles can be performed to support feasibility studies, product and material compatibility assessments, preliminary process definition and the evaluation of specific product or packaging configurations.
What Is an R&D Treatment Cycle?
An R&D Treatment Cycle is a non-validated cycle performed for research, development and pre-clinical purposes. The objective is to expose a product to defined process conditions and evaluate its response before establishing a validated sterilization process.
Depending on the sterilization technology and study objectives, parameters such as temperature, relative humidity, pressure, exposure time and process conditions can be defined and monitored.
For EO applications, the cycle can also be adapted according to EO concentration, conditioning, gas exposure and degassing requirements.
R&D Treatment Cycles are exploratory and do not replace sterilization validation. Products treated through a non-validated cycle cannot be considered sterile for commercial release on the basis of that treatment.
Material and Product Compatibility
Material compatibility is an important consideration when selecting and developing a sterilization process. Medical devices may incorporate polymers, adhesives, coatings, electronics, batteries or other components that can be affected by temperature, humidity or sterilization agent exposure.
R&D Treatment Cycles allow products and materials to be exposed to selected conditions before validation. Following treatment, the impact on product characteristics can be assessed through appropriate laboratory or functional testing.
For EO, the relatively low processing temperature and ability of the gas to penetrate packaging and complex geometries make the technology suitable for many heat-sensitive medical devices. Product-specific compatibility, however, remains an important part of process development.
Preliminary Process Parameters
During pre-clinical development, final sterilization parameters may not yet be established. R&D Treatment Cycles can be used to evaluate preliminary parameters and determine how selected conditions behave within the product and load configuration. Depending on the study, this may include the assessment of:
- Temperature and relative humidity
- Pressure profiles
- EO concentration and exposure time
- Product and packaging configuration
- Load configuration
- Degassing conditions
Environmental sensors and instrumented loads can be used to monitor process conditions at selected locations.
The information generated during these cycles can contribute to the definition of the parameters and configurations that will subsequently be evaluated during sterilization validation.
Product Geometry and Worst-Case Configurations
Product geometry can influence the distribution and penetration of sterilization conditions.
Devices containing lumens, enclosed areas, multiple components or complex assemblies may present locations that are more difficult to process. Packaging materials, product orientation and load configuration can introduce additional variables.
R&D Treatment Cycles can be used to investigate these characteristics and identify potentially challenging or worst-case configurations before validation.
Different product variants, orientations or packaging configurations can therefore be assessed under controlled conditions to support the selection of representative configurations for subsequent studies.
Supporting Pre-Clinical Feasibility Studies
An R&D Treatment Cycle can also be used as part of a broader feasibility study when the sterilization strategy has not yet been finalized. This approach enables the evaluation of a sterilization technology without requiring the complete validation framework associated with a commercial sterilization process.
Treatment can be followed by laboratory analyses to assess specific product characteristics or investigate the effects of processing.
Depending on the development program, this may include microbiological, analytical, chemical or packaging-related testing.
The objective is to generate relevant technical information during the pre-clinical phase and support decisions before progressing to formal validation.
R&D Treatment and Validated Sterilization
R&D Treatment and validated sterilization serve different purposes within the product lifecycle.
An R&D Treatment Cycle is used for exploration, feasibility and process development. It is non-validated and does not provide the documented evidence required to support a sterile claim for commercial release.
Validated sterilization requires a defined and documented process demonstrating that the required sterilization conditions can be consistently reproduced.
For medical devices, EO sterilization processes are developed, validated and routinely controlled according to ISO 11135, while moist heat sterilization processes are addressed by ISO 17665.
Once the product configuration and preliminary process conditions have been established, the project can progress from R&D Treatment to formal sterilization validation.
From Pre-Clinical Development to Routine Sterilization
Sterilization development is part of a broader product development process. Information generated during R&D Treatment Cycles can support the definition of product configurations, packaging systems, process parameters and worst-case conditions before validation.
Following successful process development and sterilization validation, the product can progress toward routine sterilization under controlled and reproducible conditions.
Medistri supports this progression through R&D Treatment Cycles, laboratory testing, sterilization validation and routine sterilization services, allowing sterilization requirements to be addressed from the pre-clinical phase through commercial production.
With sterilization and laboratory capabilities available within the same infrastructure, treatment activities can also be coordinated with subsequent testing according to the requirements of the development program.
Pre-Clinical Sterilization at Medistri
Medistri provides R&D Treatment Cycles for medical device and pharmaceutical development programs requiring controlled exposure to sterilization process conditions before validation.
Studies can be adapted according to the product, packaging configuration, sterilization technology and objectives of the development program.
The resulting data can support feasibility assessment, process development and the preparation of subsequent sterilization validation activities.
To learn more about Medistri’s R&D Treatment Cycles, please visit our website here or contact us at contact@medistri.com.
— The Medistri Team
#Medistri
Medistri is Europe's leading independent contract sterilization 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 back-end processes.
Our synchronized departments work together to provide a complete stack of services:
- Contract Sterilization & 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.
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 optimised 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 specialised 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 commercialisation.
FAQ – R&D Treatment Cycles
What is an R&D Treatment Cycle?
An R&D Treatment Cycle is a non-validated sterilization cycle used to evaluate products, materials, and packaging configurations before formal sterilization validation.
When should an R&D Treatment Cycle be performed?
It can be performed during the pre-clinical development phase when sterilization feasibility, material compatibility, or preliminary process conditions need to be assessed.
Which parameters can be evaluated during an R&D Treatment Cycle?
Depending on the sterilization technology, parameters can include temperature, humidity, pressure, exposure time, EO concentration, product configuration, and degassing conditions.
Can products treated in an R&D Treatment Cycle be considered sterile?
No. R&D Treatment Cycles are non-validated and do not provide the documented evidence required to support a sterile claim for commercial release.
Can R&D Treatment Cycles support subsequent sterilization validation?
Yes. The technical data generated can help define product configurations and process parameters for subsequent validation under ISO 11135 for EO or ISO 17665 for Steam sterilization.