SIVILAB®
MICROBIOLOGICAL STUDIES
DESCRIPTION
On the basis of Drug Manufacturing License No. Л012-00102-77/00769419 dated November 15, 2023 and the Certificate of GMP Compliance of the Eurasian Economic Union No. GMP/TAEU/RU/01031-2023 dated November 10, 2023, SIVIlab LLC conducts quality control tests in the production of medicinal products for human use.
Test objects
Substances, finished drug products (tablets, capsules, aerosols, ophthalmic drops, granules, pills, injectable dosage forms, ointments, infusions and decoctions, plasters, powders, syrups, suppositories, suspensions, extracts, emulsions, etc.) as well as research of microbiological monitoring objects of pharmaceutical production (air, water, washings).
SCIENCE
INTELLIGENCE
VERIFICATION
INDEPENDENCE
SIVILAB® performs microbiological studies according to GMP for medicinal products using the
following methods:
following methods:
- Evaluation of medicinal products antimicrobial activity
- Microbial limit, testing for specified microorganisms
- Assessment of culture media quality (growth, selective and diagnostic properties)
- Sterility testing
- Evaluation of antimicrobial agents’ efficacy
- Disinfectant efficacy validation
- Microbiological examination of purified water, water for injection and potable water
- Surface microbial contamination (washings control)
- Control of air microbial contamination
- Bacterial endotoxins (gel-clot method, turbidimetric method, chromogenic method)
- Assessment of antimicrobial activity of antibiotics by agar diffusion
Services
- 1Verification of compendial methods.
- 2Microbiological and biological procedures validation.
- 3Approbation and validation of microbiological and biological procedures for the registration of medicinal products.
- 4Transfer of microbiological procedures.
- 5Process validation: qualification of sterilization (depyrogenation) tunnels, simulation of filling process and validation of line sterility – Media Fill Test (MFT).
If you have any questions, you can receive a consultation. Please fill in the form below
and send a request.
and send a request.
If you have any questions, you can receive a consultation. Please fill in the form below and send a request.
© 2024 SIVIlab
8
Services
Contact Us
121205, Moscow, Skolkovo Technopark, Bolshoy Boulevard,
42, building 1
664048, Irkutsk, Rosa Luxemburg St., 184/1
info@sivilab.ru
42, building 1
664048, Irkutsk, Rosa Luxemburg St., 184/1
- +7 3952 550-330
info@sivilab.ru
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+ 7 (3952) 550-330