Biotechnology Sector
Biotechnology Testing, Certification and Conformity
Overview
Biotechnology sector: an overview of conformity processes
For biotechnology products, the quality-system and analytical-verification requirements overlap with pharmaceuticals; sterile manufacturing, endotoxin control and process validation stand out. Pharmaceutical or medical device legislation applies depending on the nature of the product.
How we work
Six steps from scope to certificate
Scope
We determine your product, target market and sector; the required legislation list is produced.
Quote
Testing and audit items are priced separately; the quote is delivered within 24 hours.
Sample / Planning
Sample requirements are shared, or an on-site audit is scheduled.
Testing & Audit
Testing or audit is carried out according to the method of the relevant standard.
Report & Document
A report is issued; if within certification scope, the process proceeds to the decision stage.
Maintaining the validation
Surveillance audits and legislative changes are tracked.
Product groups
Biotechnology sector: what do we test?
- 01Biological medicines and vaccines
- 02Cell and tissue products
- 03Diagnostic kits and reagents
- 04Enzymes and fermentation products
- 05Laboratory consumables
Services
The work we carry out in this sector
From testing laboratories to inspection, surveillance, audit, verification and calibration — all the services the Biotechnology supply chain needs are under one roof.
All services
Standards
Standards referenced by the sector
Content is linked to standards based on the product's intended use, target market and technical characteristics.
- ISO 14644clean rooms and related controlled environments
- ISO 4802Hydrolytic resistance of the inner surface of glass containers
- ISO 719Water resistance on glass at 98 degrees
- ISO 720hydrolytic resistance in glass at 121 degrees
- USP <1225>Validation of compendial methods
- USP <231>heavy metals (classical method)
- USP <232>limits on elemental impurities
- USP <233>Determination methods of elemental impurities
- USP <381>elastomeric caps (injectable products)
- USP <467>residual solvents
- USP <61>microbial enumeration tests
- USP <62>tests for specified microorganisms
- USP <661>plastic packaging systems and components
- USP <71>sterility testing on pharmaceutical products
- ISO 11607end product sterile barrier packaging
- ISO 11737-1determination of microbial load in medical devices
- ASTM F1980accelerated aging in packaging
- ASTM F88peeling resistance in sealing seam
- IEC 60601-1Basic safety in medical electrical devices
- IEC 60601-1-2electromagnetic compatibility in medical electrical devices
- IEC 62304medical device software lifecycle processes
- IEC 62366-1usability engineering in medical devices
- ISO 10993-10skin sensitivity assessment
- ISO 10993-11systemic toxicity
- ISO 10993-23irritation assessment
- ISO 10993-3genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-4evaluation of interaction with blood
- ISO 10993-5in vitro cytotoxicity
- AOAC 2003.06determination of fat in food
- AOAC 2005.06determination of mycotoxin (HPLC) in food
- AOAC 2007.01multiple pesticide residues in food (QuEChERS)
- AOAC 923.03determination of total ash in food
- AOAC 925.10determination of moisture in bakery products
- AOAC 984.27Calcium, copper, iron and magnesium in baby formula
- AOAC 985.29total dietary fiber in food
- AOAC 990.12aerobic plate counting in food (Petrifilm)
- AOAC 991.14Coliform and E. coli count in food
- AOAC 991.20Determination of nitrogen and protein in milk using Kjeldahl
- AOAC 996.06Determination of fatty acids and trans fats in food
- AOAC 999.10determination of lead, cadmium, zinc, copper and iron in food
- EN 1186total migration in food contact materials
- EN 12822determination of vitamin E (HPLC) in food
Certification
Documents that enable your product to reach the market
Global Market Access
Biotechnology which market will you offer your product to?
Biotechnology when offering products to different markets, technical legislation, tests, documents and conformity requirements may vary by country and region.
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