Microbiology and Testing laboratory CENTEMO has the capability, expertise and experience to offer the highest quality services in microbiology examination and testing of APIs, excipients and medicinal drugs in order to substantiate their Microbial purity and sterility.

We endeavor to ensure our support in:

• Testing of Food or Dietary Supplements compliance to the safety standards;
• Analysis to determine the Microbiological safety of beauty, personal care and cosmetic products;
• Microbial monitoring of the production environment, testing Purified water and WFI ‘in bulk’;
• Evaluation of antimicrobial activity of antibiotics by applying Agar Diffusion method;
• Detection of antimicrobial activity in medicinal drugs;
• Detection of Bacterial endotoxins by Gel-Clot technique;
• Growth promotion tests for cultural media;
• Evaluation of selective and diagnostic properties of media.

The design of the laboratory facilities provides for the clean and contaminated zones. The space-planning concept ensures the movement of PBA (Pathogenic Biological Agents) in accordance with the transition pattern for Personnel and PBA. The contaminated zone provides the appropriate arrangements for microbiological tests and examinations of the samples, handling PBA group 3-4 and their storage.  The staff entry is allowed via adjoining gowning rooms.

The staff enters the laboratory via  dedicated airlocks and a gowning room by scanning their passes at ACS points. A material transfer hatch ensures the appropriate control over the admittance of the materials for examination. The “contaminated’ Laboratory zones have integrated stand-alone plenum-and-exhaust ventilation system. H-13 filters for micro-particles provide 95.7% filtering efficiency of the supplied air. Their exhaust efficiency is 99.9995%. The over-pressure is created as equilibrium of the differential pressure in the room and ambient pressure.

The design of the laboratory facilities provides for the clean and contaminated zones. The space-planning concept ensures the movement of PBA (Pathogenic Biological Agents) in accordance with the transition pattern for Personnel and PBA. The contaminated zone provides the appropriate arrangements for microbiological tests and examinations of the samples, handling PBA group 3-4 and their storage.  The staff entry is allowed via adjoining airlocks and gowning rooms.

To handle PBA, the Class II SC Biological Safety Cabinet is installed in the enclosed Laboratory workspace. The Biosafety Cabinet complies with the appropriate technical standards and features the integrated H-14 fine filters, bactericide irradiators in the workspace and microprocessor control system.

Each cabinet is fitted with a laminar booth to run MB testing, growth media dispensing, antibiotics manipulations.

Our Laboratory is equipped with the containment isolator supplied by Extract Technology Ltd., UK

Laboratory appliances, devices, equipment and measuring instruments are certified, in operable condition, with technical data sheets and operating instructions in place. Verification is carried out by a specialized agency on a contractual basis To sterilize the air, workspaces and surfaces in all contaminated zones, the germicidal lamps are applied. Their operation is recorded in the internal log books.

The pass through autoclave provides disinfection of waste materials, remaining PBA, used laboratory glassware, solid waste from the contaminated zone.

A dedicated Autoclave room is a segregated facility where prepared growth media is sterilized in steam sterilizers (autoclave).

Our team of 11 microbiologists has a wealth of experience and competency in applying globally recognized methods and is committed to providing our clients with the top quality services. To ensure the appropriate management of hazardous PBA and related materials, every 5 years a training program in ‘Safe Handling of Pathogenic Microorganisms Group 3-4 and Organisms Causing Parasitic Diseases’ is provided.