Medical Devices
Synergy Health Pharmaceutical Laboratories' (SHPL) microbiological laboratory for mainland Europe is located in Ede, the Netherlands and offers you comprehensive support regarding the requirements for the development, manufacture and supply of medical devices. We work closely with Synergy Health AST to ensure that you have access to all the relevant knowledge and expertise. The high quality routine and bespoke testing services provide valuable support to customers with routine monitoring for controlling products, required to support product release.
SHPL's extensive experience in validating sterilization processes, and the knowledge of Synergy Health AST provides a unique and valuable combination. The high quality, routine and bespoke microbiological testing services, will ensure a safe product release and continued control over your products. Wherever your business is based, we will ensure your products meet any requirements you may stipulate.
Our microbiological testing and advice services
Please consult SHPL for plain microbiological testing but also for expert advice, troubleshooting, brainstorming or method development with regard to microbiological testing. We conduct and validate a full range of tests. We have summarized the key areas.
| Microbiological Services |
Method 1 acc. ISO 11137-2 |
Method VDmax25 acc. ISO 11137-2 |
Accelerated Aging Tests acc. ASTM F1980-07 "Standard guide for accelerated aging of sterile barrier systems for medical devices" |
Routine microbiological laboratory tests, for instance bioburden testing, sterility testing, identification of micro-organisms |
Environmental Monitoring for production and cleanroom locations |
Endotoxin / LAL testing |
For our extensive portfolio list of services and contact overview, please click
here.
| Additional Services |
Consultancy and training |
On-site troubleshooting |
Performing in-house verification experiments by means of Gamma irradiation by our own Gamma sites in the Netherlands, Germany, France or UK |
Support from RegiLabs Chemical / Pharmaceutical lab (Utrecht, the Netherlands) |
Extensive knowledge / Company database |
Logistics Support |
Industry expertise
SHPL's location in Ede is ISO 9001 / ISO 13485 / ISO 11137-1 / GMP certified. Furthermore, our facilities in Ede are inspected by the US-FDA.
If you would like further information or have any specific questions, please complete our contact
form.
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