Laboratory for Microbiological Control of Food and Water
The laboratory has implemented the quality system - MKC EN ISO 17025:2018, as part of the program and routine activities, provides for the performance of the following analyses:
- Microbiological control of air, wipes from work surfaces and hands of food industry employees;
- Microbiological control of items for general use;
- Drug testing laboratory – sterility of finished drugs and medical devices that are declared sterile (Ph. Eur. 2.6.1);
- Microbiological purity of raw materials for medicines, finished pharmaceutical forms, primary packaging (Ph.Eur 5.1.4);
- Microbiological purity of herbal medicinal products and extracts (Ph.Eur 5.1.8);
- Microbiological purity of cosmetic products (Official Gazette 94/2010).
The laboratory from May 2008. is accredited with ISO 17025 and works in accordance with the legal regulation for testing the microbiological correctness of food "Regulations for special requirements for food safety in relation to microbiological criteria" (Official Gazette of the Republic of Macedonia 100/2013; 229/2020).
Laboratory for microbiological control of drugs, sterility and cosmetic preparations
- testing the sterility of drugs using membrane filtration and direct seeding methods, including preparations for parenteral application and other medical products that are declared sterile, such as eye drops, medical devices, etc.;
- Bacteriological purity testing of all dosage forms used orally, locally or rectally, including tablets, capsules, suppositories, creams, ointments, vagitories, as well as other preparations that may be of synthetic origin or of organic (plant, mineral or animal) origin by the method of direct planting on a suitably prepared sample or by the method of membrane filtration;
- examination of bacteriological purity of water for pharmaceutical purposes by membrane filtration method;
- examination of bacteriological purity of primary packaging such as capsules, Al-foils, PVC-foils, glass bottles, plastic vials, droppers, alveoli for suppositories and other packaging by means of aspiration or the method of taking a swab and directly inoculating the thus prepared sample ;
- examination of the bacteriological purity of medical cosmetics and cosmetic preparations that find daily use among the general population, such as means for maintaining personal hygiene and means for beautifying the face and body; Modernization and re-equipment of the laboratories with laboratory equipment is also a priority for this laboratory, as well as starting the accreditation process of the laboratory for the control of drugs and cosmetic products and preparations for the implementation of the ISO 17025 and ISO 15189 standards.
- - Bacterial endotoxin testing laboratory within its work, the unit has implemented the quality system - MKCENISO 17025:2018.