With increasing attention directed toward bio / pharmaceutical product safety, the importance of screening for trace metal contamination is becoming more important. Eurofins BPT competence center in Denmark offers an array of testing services for a verity of applications that contribute to the product integrity, including drug substance and raw materials assay, media screening, extractable/leachable studies and final product assay.
ICH Q3D and the new USP <233> is an example of specific regulatory changes forcing the use of ICP MS and ICP AES in a GMP setting.
To detect even minor differences in metal levels for specific samples Eurofins BPT offers to detect down to ppt level, due to the extensive possibilities for sample pre-treatment in microwaves and other sample preparation techniques as well as the specially designed high pressure room to safeguard samples from contaminating air particles
Eurofins BPT offers the complete range of metal testing services for the pharmaceutical industry including
Eurofins BPT operate according to cGMP and is approved by the Danish Health Authorities and registered with FDA.
Eurofins BPT provides a number of approaches to meet the specific client requirements, including the following;
Eurofins BPT can help determine the instrumentation and sample preparation that best meets testing needs and provide general instrument performance advice. For example, sensitivity limits are dependent on choice of instrumentation, sample digestion approach and available sample mass.
Eurofins BPT is proud to offer our clients a high level and very well documented quality service to international standards.
All equipment is installed with 21 CFR Part 11 compliant software and is qualified according to US and European quality requirements.
Eurofins BPT DK is regularly audited by FDA and European health authorities.
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