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Meeting your needs
SHPL offers customised services for businesses and applications in the following markets:
 
Pharmaceuticals
Medical Devices
Veterinary
Homeopathy
Cosmetics
Hospitals
Pharmacies
Other Markets
 
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  Medical Devices
Ing. H. Huppes-Rodenburg
  Validation and routine monitoring of the production process and sterilization procedures of medical devices.
 
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  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.

 
 
ISO 9001-2008 Certified © 2012 Synergy Health Pharmaceutical Laboratories