Division of Microbiological Control of Food and Drugs

Division of Microbiological Control of Food and Drugs, within the Department of Microbiology

Information about the activity performed in Division of Microbiological Control of Food and Drugs

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:

  1. Microbiological control of air, wipes from work surfaces and hands of food industry employees;
  2. Microbiological control of items for general use;
  3. Drug testing laboratory – sterility of finished drugs and medical devices that are declared sterile (Ph. Eur. 2.6.1);
  4. Microbiological purity of raw materials for medicines, finished pharmaceutical forms, primary packaging (Ph.Eur 5.1.4);
  5. Microbiological purity of herbal medicinal products and extracts (Ph.Eur 5.1.8);
  6. 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

  1. 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.;
  2. 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;
  3. examination of bacteriological purity of water for pharmaceutical purposes by membrane filtration method;
  4. 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 ;
  5. 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.
  6. - Bacterial endotoxin testing laboratory within its work, the unit has implemented the quality system - MKCENISO 17025:2018.


Measures and activities under the competence of the Division of Microbiological Control of Food and Drugs

Laboratory for Microbiological Control of Food and Water

The laboratory operates the following parameters:


  1. Detection and identification of Salmonella (ISO 6579 : 2017);
  2. Demonstration of coagulase positive Staphylococcae (ISO 6888-1: 2008);
  3. Enumeration of Sulfide-Reducing Clostridii (ISO 15213:2003);
  4. Enumeration of Clostridium perfringer (ISO 7937: 2004);
  5. Enumeration of beta glucoronidase positive E. coli (ISO 1664 –2: 2017);
  6. Proof of E. Coli 0157:H7 (ISO 16654 : 2001);
  7. Proof of Listeria monocytogenes (ISO 11290-2: 2018);
  8. Demonstration of Campilobacter spp (ISO 10272 - 1: 2017);
  9. Proof of Yersinia enterocolitica (ISO 10273 - 2017);
  10. Proof of Bacilus cereus (ISO 7932: 2020);
  11. Demonstration of Enterobacteriaceae (ISO 21528-2: 2017);
  12. Proof of Cronobacter sakazakii (ISO/TS 22964: 2017);
  13. Detection of Vibrio parahemolyticus (ISO 8914: 2007);
  14. Demonstration of Lactobacilli;
  15. Demonstration of Streptococcus species;
  16. Enumeration of total aerobic mesophilic bacteria (ISO 4833: 2013);
  17. Enumeration of yeasts and molds (ISO 21527-1,2: 2008);
  18. Proof of VIDAS Salmonella (SPT) ELFA method (AFNOR certificate);
  19. Proof of VIDAS L.monocytogenes Xpres (LMX) ELFA method (AFNOR certificate);
  20. Proof of VIDAS E.coli 157:H7 (ECPT) ELFAmethod (AFNOR certificate);
  21. Proof of VIDAS Campylobacter (CAM) ELFA method (AFNOR certificate);
  22. Demonstration of VIDAS Staph enterotoxin (SET2) ELFA method (AOAC certificate);

Laboratory for microbiological control of drugs, sterility and cosmetic preparations

Analyzes that are performed according to valid standards and methods (Ph.Eur/USP/BP) are:

  1. Examination of the presence/absence of bacterial endotoxin in parenteral preparations for human use, substances for pharmaceutical use, preparation for irrigation with the gel clot method;
  2. Examination of the presence/absence of bacterial endotoxin in medicinal preparations (par enteral drugs for human use, serums, vaccines, substances for pharmaceutical purposes, irrigation preparations, hemodialysis water, hemodialysis solutions) according to the specifications and methods described in the current editions of the European Pharmacopoeia (Ph.Eur.), the United States Pharmacopoeia (USP), The British Pharmacopoeia (BP) as well as the specifications and validated methods of the manufacturer of the finished preparation (Ph. Eur. 2.6.14, LAL test - Gel clot method, accredited method according to MKC EN ISO/IEC 17025:2018);
  3. The bacterial endotoxin testing laboratory foresees the introduction of a test for bacterial endotoxin in medical devices with the gel clot technique;
  4. Bacterial endotoxin testing provided by the Agency for Medicines and Medical Devices of the RNM, Public Health Institutions with which the Institute has concluded an agreement, as well as by private legal entities.

Contact information

Contact person: prim. Elizabeta Coneva, MD, spec. in microbiology

Contact phone: +389 70 761 723

Email elizabetaconeva@yahoo.com