Products and raw materials
MEDICINAL PRODUCTS, PRODUCTS IN THE AGEING CYCLE, RAW MATERIALS, INCLUDING ACTIVE SUBSTANCES AND HERBS
All non-sterile medicinal products on the market must fulfil certain criteria of microbiological purity. Proper microbiological control ensures receiving a safe product of high quality. According to the GMP rules and applicable law, pharmaceutical manufacturers are obliged to ensure the safety and stability of offered products. Therefore, stability testing of medicinal products is one of the major activities to assess long-term quality.
It is used in marketing tests of a new product to determine its expiry date and routine marketing of a product series to confirm its high quality. A pure pharmaceutical raw material forms the basis for the manufacturing of both medicinal and other products. With good microbiological control, you can verify a supplier, ensure you are using raw material of good quality and prevent financial losses resulting from low quality of the manufactured products. The legislator has introduced requirements concerning the permissible contamination with bacteria and yeast in pharmaceutical raw materials. This parameter is specified in a detailed monograph of a material.
BIO-CHIC Microbiological Laboratory means certified reliability of test results and technical competence.
We are one of the few microbiological laboratories in Poland to have been PCA-accredited for medicinal products and raw materials according to FP and Ph.Eur.
Our offer includes testing of:
total microbial count in g/ml of a product;
total yeast and mould count in g/ml of a product;
presence of Staphylococcus aureus,
presence of Pseudomonas aeruginosa,
presence of E.coli,
presence of Salmonella,
presence of Enterobacteriaceae and other Gram-negative bacilli
presence of Clostridium anaerobic bacilli;
COSMETICS, COSMETIC RAW MATERIALS AND HOUSEHOLD CHEMICALS
Cosmetics belong to the group of consumer products. They are mass-produced and used from early childhood until late adulthood. Their purpose is to improve and protect our bodies, so they need to be safe to use. Good quality cosmetic products protect the health of users and prevent economic losses for manufacturers.
We test cosmetics in accordance with Polish Standards:
- PN-EN ISO 22718:2016 Cosmetics. Microbiology Detecting the presence of Staphylococcus aureus
- PN-EN ISO 22717:2016 Cosmetics. Microbiology Detecting the presence of Pseudomonas aeruginosa
- PN-EN ISO 21150:2016 Cosmetics. Microbiology Detecting the presence of Escherichia coli
- PN-EN ISO 18416:2016 Cosmetics. Microbiology. Detecting Candida albicans
- PN-EN ISO 16212:2017 Cosmetics. Microbiology Determining the total number of yeasts and moulds
- PN-EN ISO 21149:2017 Cosmetics. Microbiology Counting and detection of aerobic mesophilic bacteria.
The Regulation of the European Parliament on cosmetic products requires manufactures of cosmetics to have a product safety report. A challenge test is necessary to confirm that despite containing preservatives the product poses no hazard to health.
The test is performed for cosmetic as well as pharmaceutical products. An appropriate pharmacopoeial method is presented in the monograph (5.1.3. Efficacy of antimicrobial preservation)
BIO-CHIC Microbiological Laboratory has been performing Tests on the Efficacy of Microbial Preservation for many years, helping its partners to select a preservative and its lowest effective dose.
We perform tests in line with:
- Polish and European Pharmacopoeia
- PN-EN ISO 11930:2019