Product and raw materials

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. Note that in the case of investigational medicinal products there is an additional risk for study participants as compared to patients taking medicines available on the market. The manufacturing of these products must be performed according to any and all GMP rules to prevent adverse effects on the health and life of the participants.

BIO-CHIC Microbiological Laboratory means certified reliability of test results and technical competence.

We offer tests according to the Polish Pharmacopoeia (FP), European Pharmacopoeia (Ph.Eur), validation reports or Customer’s methodology.

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 Escherichia coli,
• presence of Salmonella,
• presence of Enterobacteriaceae and other Gram-negative bacteria
• presence of Clostridium;

Raw materials, including active substances and herbs, for medicinal products and cosmetics

A pure pharmaceutical or cosmetic 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 a 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.

Tests of raw materials are performed according to the Polish Pharmacopeia, European Pharmacopeia, Polish Standards (PN), and the Regulation of the Minister of Health of 23 December 2002, or Customer’s methodology

with respect to:

• 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 Escherichia coli,
• presence of Salmonella,
• presence of Enterobacteriaceae and other Gram-negative bacteria,
• presence of Clostridium;

Cosmetics and home care products

Cosmetics belong to the group of consumer products. They are mass-produced and used from an early childhood until late adulthood. Their purpose is to improve and protect our bodies, so they need to be safe to use. Good quality of cosmetic products protects the health of users and prevents economic losses of manufacturers.

We are one of the few microbiological laboratories in Poland to have been PCA-accredited for cosmetic testing:

1. 1. PN-EN ISO 22718:2016 Cosmetics. Microbiology. Detection of Staphylococcus aureus
   2. PN-EN ISO 22717:2016 Cosmetics. Microbiology. Detection of Pseudomonas aeruginosa
   3. PN-EN ISO 21150:2016 Cosmetics. Microbiology. Detection of Escherichia coli
   4. PN-EN ISO 18416:2016 Cosmetics. Microbiology. Detection of Candida albicans
   5. PN-EN ISO 16212:2017 Cosmetics. Microbiology. Enumeration of yeast and mould
   6. PN-EN ISO 21149:2017 Cosmetics. Microbiology. Enumeration and detection of aerobic mesophilic bacteria

We also offer testing according to the Regulation of the Minister of Health of 23 December 2002 and methods arranged with the Customer.

Products in aging cycle

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.

According to the GMP rules and applicable law pharmaceutical and cosmetic manufacturers are obliged to ensure the safety and stability of offered products.

We perform product purity testing in the course of aging tests according to the Customer’s specification, Polish and European Pharmacopoeia.

We perform tests with regard to:

• 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 Escherichia coli,
• presence of Salmonella,
• presence of Enterobacteriaceae and other Gram-negative bacteria
• presence of Clostridium;

Challange tests

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:

1. Polish and European Pharmacopoeia

2. PN-EN ISO 11930:2012

3. KOKO TEST Method