In the pharmaceutical industry, sterile products refer to the products that are going to be infused directly into the body tissue or bloodstream. Non-sterile products refer to the products that are going to be administered using an enteral route. Creative Animodel provides different microbiology testing services for sterile products and non-sterile products to help you develop safe compounds and biologics that are compliant with standards of regulatory agencies.
Services for Sterile ProductsSterility testing
There are two options for sterility testing: direct inoculation and membrane filtration. The direct inoculation method is to inoculate the test samples into two different types of media that support the growth of aerobic and anaerobic bacteria. The membrane filtration method can solve issues such as large volumes of test article and the presence of inhibitors of microbial growth on samples.Endotoxin testing
An endotoxin testing is essential for therapeutic products manufactured in bacteria to ensure that these products are endotoxin free. Lipopolysaccharides (LPS) are typical Gram-negative bacterial endotoxins that are known to cause fevers, liver damage, coagulation disorder and other diseases. Creative Animodel offers the limulus amoebocyte lysate (LAL) assay by gel-clot methods or chromogenic methods for both quantitative and qualitative endotoxin evaluation.Bioburden testing
A bioburden testing is referred to as a total viable count (TVC) testing to determine the total number of viable microorganisms in products purported to be sterile. It is a regulatory requirement for investigational new drug (IND) applications and is critical for drug development. The bioburden testing can act as an early warning system for possible production problems. It can also provide an accurate basis for calculating effective sterilization doses for a given therapeutic.
Services for Non-sterile ProductsPreservative efficacy testing
A preservative efficacy testing (PET), also known as a challenge testing, simulates contamination through microorganism inoculations over a period of time and assesses the ability of the preservative to reduce or eradicate these microorganisms. This test should be performed on all aqueous-based products, such as injections, oral solutions, dialysis fluids, and ointments. Creative Animodel has extensive experience working with United States Pharmacopoeia (USP) organisms, and an excellent understanding of preservative systems and techniques.Microbial limits testing
Microbial limits testing (MLT) is a critical part of good manufacturing practice (GMP) to determine whether a product complies with pharmacopeia specifications for microbial quality. Our company provides both qualitative phase and quantitative phase MLT services. The qualitative phase determines the presence or absence of specific objectionable organism in a product. The quantitative phase determines the total number of aerobic organisms, yeast, and mold on a product.
In addition to above services, Creative Animodel also provides custom microbiology testing services to meet your specific needs. If you have any questions, please feel free to contact us.