Validation Services at Andersen Caledonia
At Andersen Caledonia, our expert team validate your medical devices and processes to meet certain industry standards. Whether you need to revalidate an existing procedure or are going to market with a new product – we make this complicated task seamless and easy for you. All process analysis and test results from the validation process are documented in a final report giving you full traceability and transparency from start to finish. Our team maintain continuous communication with our customers throughout the validation process ensuring you are up-to-date regarding the outcome at each stage.
What is a Validation?
Validation is critical for healthcare, life science, and biotechnology companies to showcase industry compliance. Sterilisation is a process where the outcome cannot be verified by inspection or testing. Process validation is therefore essential to justify a claim of sterility. Validation will include both a physical and microbial qualification and will comply with the relevant ISO standards for Steam and Ethylene Oxide (EtO). The validation will be undertaken using the device to be sterilized in its final form and within a sterile barrier.
Sterilisation Validation
at Andersen Caledonia
Our experienced Validation Team liaise with our customers to develop the most suitable process for your product to demonstrate compliance with the relevant ISO standards. This enables you to submit compliant technical files to notified bodies. Our sterilisation validation services are performed for medical device manufacturers, BioTech startups, and MedTech organisations that may have or aspire to have a CE Mark and will also allow you to make a sterility assurance claim for your products.
Ethylene Oxide Sterilisation Validation
Our Ethylene Oxide validations are carried out in accordance with ISO11135 Annex B & E (Overkill Method or Single lot). Validations can also be carried out to other annexes if required. Ethylene Oxide Sterilisation uses a multi-stage process which includes pre-conditioning of products within a controlled environment, sterilisation of products using ethylene oxide gas, and aeration of products to ensure gas dissipation. This results in sterile products with a safe level of, or no, residual gas.
Steam Sterilisation Validation
Our Steam Sterilisation validations are carried out in accordance with ISO17665 or HTM guidance documents. During steam sterilisation, our chambers control the four key parameters of steam (moist heat), pressure (aiding to obtain the necessary temperatures), temperature and time.
Instructions For Use (IFU) Validation of Re-Usable Medical Devices
All reusable medical devices that are used in a sterile state require details for reprocessing in their instructions for use. These reprocessing instructions include cleaning and sterilisation and must be written and validated in accordance with the requirements of ISO17664. Andersen Caledonia has over a decade of experience in developing reprocessing instructions for use that meet the multiple requirements of different regulatory authorities and users across the globe. We benefit from having access in-house to instrument washers/disinfectors and autoclaves that match those found in a hospital sterile processing department plus a well-equipped laboratory able to test for proteins as well as micro-organisms.
Our reprocessing validations are carried out in accordance with ISO 17664, ASTM E2314 and associated international testing standards. The validation will evaluate the effectiveness of the cleaning, disinfection and sterilisation detailed in your Instruction For Use (IFU) and to make a claim that your IFU meets the relevant international standards. We can also verify the maximum number of re-uses limit. Processes validated with associated testing can be a mixture of the following:
- Manual Cleaning
- Automated Cleaning
- Ethylene Oxide Sterilisation (EtO/EO)
- Steam Sterilisation
Validation of Sterile Packing
Our sterile packing validations are carried out in accordance with ISO11607, associated ageing standards and associated packaging testing standards. We continue to validate the packaging process for pharma (biopharma, pharmaceutical manufacturing, etc.), NHS, and life science companies.
These validations consist of:
- Accelerated ageing with associated testing
- Real-time ageing with associated testing
- Routine seal strength testing for sealing verification
- Routine integrity testing for sealing verification
Validation of Sterility Shelf Life
All sterile devices are issued with an expiry date when the sterility can no longer be guaranteed. This expiry date requires validation in accordance with ISO11607. Andersen Caledonia operates a full validation service including real & accelerated ageing, sterile barrier & sterility testing and arranging transportation studies.
Bioburden Validation and Analysis
Bioburden validation analysis identifies the number of harmful microorganisms and pathogens that are present on a medical device/material. This quantification of bacteria that is living on a surface provides you with an accurate number for understanding how effective your current sterilisation process is working. Our bioburden testing validation gives you data that allows you to make effective, high-level decisions on your sterilisation activity and whether improvements are needed to enhance safety from malignant bacteria.
