The CD formulation offers several methods for microbial limit testing

0


As an expert in drug formulation, CD Formulation announces the launch of a microbial limit testing (MLT) service for drug development projects to determine if a non-sterile pharmaceutical product meets established specifications .

New York, United States – October 26, 2021 – A high level of microorganisms should not be present in non-sterile products for human use as they can cause undesirable incidents. As an expert specializing in drug formulation, CD Formulation announces the release microbial limit test (MLT) for drug development projects to determine if a non-sterile pharmaceutical product meets established specifications.

Microbial safety is very important for drugs and must be carefully monitored at all stages of drug development, including manufacture and subsequent stages of storage and use. By setting limits on the number of bacteria, you will ensure the safety of pharmaceutical products.

“We know that solid oral dosage formulations, such as pills and tablets, are manufactured and sold worldwide as non-sterile formulations. By conducting a MLT, the number of microorganisms present in non-sterile pharmaceutical samples, whether raw materials or finished products, can be specified to determine whether certain microorganisms exceed quantitative limits, ”explains the CD formulation marketing manager.

With a cGMP compliant laboratory and state of the art analytical instruments, CD Formulation is able to perform microbial limit testing for the pharmaceutical and cosmetic industries according to USP and EP. There are many analytical techniques to assess MLT, and the most commonly used methods are membrane filtration method, standard plate count, pour plate method, most probable number, direct enrichment, enrichment by membrane filtration, etc.

Usually, a microbial limit test begins with system suitability, a step taken initially to determine whether the product being tested will enhance or inhibit bacterial or fungal growth. Once the suitability of the system is determined, the next step is total aerobic counting, in which the bioburden of the product, i.e. the amount of bacterial contamination, can be determined in a given amount of sample. At the same time, the total yeast and mold count (TYMC) is also performed in the same way as the total aerobic count, although there are some differences.

Guided by USP and EP, CD Formulation provides the following microbial limit testing services:

• Suitability test of the MLT method
• Microbial enumeration (total number of aerobic microbes and total combined number of yeasts and molds)
• Test for specified microorganisms (including P. aeruginosa, E. coli, S. aureus, Salmonella, Gram-negative bile tolerant bacteria, C. albicans, Clostridium, Burkholderia cepacia complex)

For more information on CD Formulation’s microbial limit testing services, please visit https://www.formulationbio.com/microbial-limits-test.html or send an email directly to [email protected]

About CD formulation

As a science-driven company, CD Formulation has accumulated rich experience in drug formulation and is qualified to serve the pharmaceutical industry by providing CRO services to develop, produce and design pharmaceutical excipients for solid dosage forms. , semi-solids and liquids. With an innovative mind and a down-to-earth attitude, the company is on a mission to solve the long-standing problem of developing new APIs such as API-excipient compatibility. It has successfully completed several development projects and proudly extends its capabilities, which range from generic to innovative formulation with the ambition of improving the solubility and bioavailability of difficult-to-formulate compounds.

Media contact
Company Name: CD-ROM
Contact: Helene smith
E-mail: Send an email
Telephone: 1-631-372-1052
Country: United States
Website: https://www.formulationbio.com


Share.

Leave A Reply