SIVILAB®

MICROBIOLOGICAL STUDIES

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).

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.

DESCRIPTION

Test objects

SCIENCE  INTELLIGENCE  VERIFICATION  INDEPENDENCE

SIVILAB® performs microbiological studies according to GMP for medicinal products using the
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

SIVILAB® performs microbiological studies according to GMP for medicinal products using the
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

1

Verification of compendial methods.
2

Microbiological and biological procedures validation.
3

Approbation and validation of microbiological and biological procedures for the registration of medicinal products.
4

Transfer of microbiological procedures.
5

Process validation: qualification of sterilization (depyrogenation) tunnels, simulation of filling process and validation of line sterility – Media Fill Test (MFT).

1

Verification of compendial methods.
2

Microbiological and biological procedures validation.
3

Approbation and validation of microbiological and biological procedures for the registration of medicinal products.
4

Transfer of microbiological procedures.
5

Process validation: qualification of sterilization (depyrogenation) tunnels, simulation of filling process and validation of line sterility – Media Fill Test (MFT).