Drug Microbial Limit Testing

Creative Proteomics provides a drug microbial limit testing platform to help you understand the degree of microbial contamination of non-sterile preparations and their raw materials and auxiliary materials, which complies with legal regulations.

As a drug manufacturing enterprise, it is essential to ensure the microbiological safety of drugs. Drug microbial limit testing is not only a method to determine the degree of microbial contamination of drugs, but also an important comprehensive basis to hygienic evaluation of the equipments and instruments, technological process, production environment and the sanitary condition of the operators in the production enterprises.

Creative Proteomics has developed a rapid testing platform suitable for drug manufacturing enterprises and government organizations, which can be used for the analysis of the number of bacteria, mold and yeast, control bacteria and other microorganisms of the entrusted sample, and issue the drug microbial limit testing report in accordance with the quality assurance/quality control plans and regulations of each country/region and your special requirements.

Detectable Products

We can provide you with the following types of drugs, raw and auxiliary materials testing, including but not limited to:

DRUGS, RAW AND AUXILIARY MATERIALS CAN BE ANALYZED AT CREATIVE PROTEOMICS
Oral preparationsLiquid pharmaceutical preparations
Semisolid preparation
Oral solid preparations
External preparationsAll other external preparations, except ophthalmic preparations and marked aseptic drugs
Raw and auxiliary materialsMedicinal raw and auxiliary materials containing bacteria

Available Services for Drug Microbial Limit Testing

  • The total number of aerobic bacteria testing
  • Creative Proteomics can assist clients in testing the number of live aerobic bacteria (including bacteria and fungi) contaminated by a unit weight, volume, or area (g, mI, or 10 cm2) of non-sterile pharmaceutical preparations.

    • AGAR method. This service is suitable for the samples with high bacteria content.
    • Membrane-filter procedure. This service is suitable for the samples that have antibacterial activity or contain low amount of bacteria.
    • Most probable number (MPN) method. This service is suitable for samples with too low bacterial content to be tested by the first two methods.
  • The total number of mold and yeast testing
  • Creative Proteomics can assist clients in testing the number of live mold and yeast contaminated by a unit weight, volume, or area (g, mI, or 10 cm2) of non-sterile pharmaceutical preparations.

    • AGAR method. This service is suitable for the samples with high mold and yeast content.
    • Membrane-filter procedure. This service is suitable for the samples that have antibacterial activity or contain low amount of mold and yeast.
  • Control bacteria testing
    • Cholate tolerant gram-negative bacteria. Creative Proteomics can provide service that tests gram-negative bacteria which can survive and reproduce in bile acid respiratory of inhaled drug administration preparations, oral preparation of traditional Chinese medicine, Chinese herbal extracts and traditional Chinese medicine decoction pieces, and compare with the limit standard.
    • Escherichia coli. Creative Proteomics can provide service that tests Escherichia coli of oral and respiratory administration preparations.
    • Pseudomonas aeruginosa. Creative Proteomics can provide service that tests pseudomonas aeruginosa of the topical preparation for local administration.

Technology Platform

  • Microbial limit tester
  • Microbial limit test room complies with legal regulations
  • Complete supporting biotechnology platform

Turnaround Time: Depending on the different incubation time, we will complete it as quickly as possible to save your time cost.

At Creative Proteomics, our professional analysts can provide you with improved quality services to support your business. Our professional analysis platform can guarantee consistently accurate and detailed delivery. If the substance or item you want to test is not in the above content, please contact us. Our professionals will customize exclusive solutions for you. Creative Proteomics looks forward to cooperating with you.

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