Our Laboratory Services
Our radiation and ethylene oxide services are fully supported by a network of 15 laboratories in Europe, Africa, Asia, Costa Rica and the USA.
STERIS Pharmaceutical Laboratories and Biotest Laboratories are now STERIS Laboratories
Please go here to learn about our new global branding, effective February 15, 2017.
STERIS Pharmaceutical Laboratories | EMEA
As a contract laboratory STERIS Pharmaceutical Laboratories provides a wide range of services through 9 sites in the EMEA region.
Combining over half a century of experience in pharmaceutical product testing with the STERIS market leading position in medical device sterilization, STERIS Pharmaceutical Laboratories offers internationally recognized centers of excellence in pharmaceutical & medical device testing. Honesty and integrity are essential in building relationships that benefit our Customers and we build local relationships with global support in the areas of regulations, experience and standards.
We are the experts
With extensive expertise of the European pharmaceutical market. Offering on-going consultancy and support by good listening and working closely with our Customers
- Wide range of services (both microbiological and chemical)
- A highly trusted partner, known for transparency, flexibility and reliability
- An outstanding team of experienced scientists and lab technicians
- Fully qualified to international standards (GMP, ISO 9001, ISO 13485 certified, WHO accredited and NL-IGZ and U.S. FDA inspected)
- Scientific knowledge network
- High quality service and short lead times
When you work with STERIS Pharmaceutical Laboratories, you enjoy a close working relationship with direct access to our team of experts for your project or routine analysis, so you can be fully aware of your project status at all times.
Our sales managers are available to respond to any questions you may have. We pride ourselves on being exceptionally open and flexible – if your requirements change mid-project, we will always do our utmost to help you meet your new objectives. Equally, we always let our Customers know of any developments that may affect them in any way.
We will work with you to find a cost effective solution to meet your regulatory requirements and your production deadlines.
Services of STERIS Pharmaceutical Laboratories
- Medical devices
- Raw Material analysis
- Drug Product analysis
- Stability Studies
- Microbiological & pharmaceutical testing
- Cosmetic analysis
Biotest Laboratories, Inc. | USA
Biotest Laboratories makes life-saving products possible through laboratory testing, validation planning, manufacturing, steam sterilization and reusable device qualifications for the medical device industry.
Founded in 1988 as a manufacturer and test laboratory for the medical products industry. Our service facility is located in the Brooklyn Park suburb of Minneapolis, Minnesota, USA.
Since its founding, the company has grown to offer its current line of services, including:
- Laboratory Testing
- Validation Services
- Manufacturing & Packaging
- Reusable Device Qualification
We also offer training and consulting services specifically designed to meet our Customers’ needs.
To meet the growing Customer requests, Biotest Laboratories recently expanded to a new 75,500-square-foot facility with Class 7 and Class 5 clean room areas. Biotest Laboratories is committed to a program of quality processes, products, and services. Biotest Laboratories, Inc. was acquired by STERIS Corporation in March 2012.
Biotest Laboratories Is Committed to a Program of Quality Processes Compliant with Applicable Recognized Standards, Customer Specifications, and Improvement of the Quality System. It is our fundamental belief that our quality system should equal or exceed the system of our Customers.
Certifications: U.S. FDA 21 CFR §211 and §820 | ISO 13485:2003 | ISO/IEC 17025:2005 | EN/ISO 17665
Biotest Laboratories is an internationally recognized authority in GMP compliance, sterilization and manufacturing of sterile medical products. Biotest Laboratories personnel have published numerous articles, and serve as presenters, committee members and course instructors for various organizations such as:
- U.S. Food and Drug Administration (FDA)
- Parenteral Drug Association (PDA)
- Medical Device and Diagnostic Industries (MD&DI)
- American Society of Microbiology (ASM)
- International Society of Pharmaceutical Engineers (ISPE)
- USP XXII Sterilization Indicators Expert Advisory Committee
- Co-Chair: AAMI Biological Indicator and Industrial Moist Heat Sterilization Committees
- Life Science Alley