Bioburden Testing Services for Live Biotherapeutic Products
Introduction Services Case Study FAQs
With the help of abundant experience and professional scientists, Creative Biolabs is committed to guiding global customers to bioburden testing solutions. We are always dedicated to assisting our clients with the most satisfactory live biotherapeutic product development services.
Introduction of Bioburden
Manufacturing of pharmaceutical products, whether small molecules or biotherapeutics such as oligonucleotides, monoclonal antibodies, recombinant proteins, vaccines, and blood and plasma products are under regulatory control which demands various safety, efficacy, and quality measures. Bioburden is usually defined as the population of bacteria living on an unsterilized surface. Bioburden can affect the stability and effectiveness of live biotherapeutic products. Bioburden monitoring is necessary for both sterile and non-sterile product manufacturing. With sterile manufacturing, bioburden assessment provides information about the microbial content of the product up to the point of sterilization. With non-sterile products, bioburden assessment informs the manufacturer about both the expected microbial load of the product and the presence or absence of specific microorganisms. Microbiological quality of the pharmaceutical formulation is a crucial attribute as small numbers of organisms (yeast, mold, and bacteria, including Pseudomonas spp. and members of Enterobacteriaceae) introduced into a product during manufacture or use may be of little consequence to the patient, where these organisms undergo subsequent multiplication within the product the infection hazard will be significantly increased.
Bioburden Testing Services
Bacterial contamination control in pharmaceutical products is an important aspect of the pharmaceutical industry as it poses a risk to the health and possibly life of the patient. Bioburden testing is an important part of pharmaceutical microbiology, which can provide data for the quality of drugs in the manufacturing process.
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Microbial Enumeration
Total Aerobic Microbial Count (TAMC)
Total Yeast and Mold Count (TYMC)
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Specified Organisms Testing
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Suitability of the Test Method
Testing Method
To assess the level of microbial content during processing, bioburden testing involves an estimation of the number of bacteria and fungi present in a liquid or solid sample. This is usually performed using the total viable count (TVC) method. The commonly used TVC methods are: membrane filtration, pour plate or plate spreading, and another method is the most probable number (MPN) method.
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Membrane filtration method
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Standard plate count
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Most probable number
Sample Specifications
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It is recommended to supply 30-50 grams/mL for the USP <61> and <62> suitability test.
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It is recommended to supply 20-40 grams/mL/patches/doses for the testing.
Turnaround Time
Suitability of the test method: 2-4 weeks
Microbial enumeration: 3-4 weeks
Applicable Standards
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USP <61> Microbial Enumeration
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USP <62> Specified Microorganisms
This will allow the determination of the absence of, or limited occurrence of, specified microorganisms that may be detected under the conditions described.
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USP <1111> Microbial Quality
Acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use.
Test Microorganisms
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USP <61>
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USP <62>
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Staphylococcus aureus
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Staphylococcus aureus
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Pseudomonas aeruginosa
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Pseudomonas aeruginosa
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Candida albicans
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Escherichia coli
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Aspergillus niger
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Salmonella enterica
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Aspergillus brasiliensis
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Candida albicans
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Case Study
Project: Microbial Stability Study of Non-sterile Aqueous Oral Solution
Objective: This study was to confirm the suitability of the counting method and the Escherichia coli test method according to the USP <61> and USP <62> for the oral solution. Once method suitability was determined, the non-sterile oral solution (Aqueous solution) product bioburden was evaluated (under different storage conditions).
Acceptance Criteria for Microbiological Quality of Non-sterile Aqueous Oral Solution
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Route of Administration
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TAMC (cfu/g or cfu/ml)
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TYMC (cfu/g or cfu/ml)
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Specified Microorganism
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Aqueous preparations for oral use
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102
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101
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Absence of Escherichia coli (1 g or 1 mL)
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Results (Partial)
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Analysis
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Time Intervals
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Acceptance Criteria
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Quality Remarks
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Day 0
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Day 15
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Day 30
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TAMC - USP <61> (cfu/mL)
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<1
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<1
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<1
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102
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Pass
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TYMC - USP <61> (cfu/mL)
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<1
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<1
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<1
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101
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Pass
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Escherichia coli – USP <62> (cfu/mL)
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Negative
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Negative
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Negative
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Absence
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Pass
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Creative Biolabs has built a team of experienced scientists with facilities and processes designed specifically to provide the best strategy and protocols customized to bioburden determination services. We have accomplished many projects for detecting the number of viable microorganisms in a range of therapeutic areas. If you have any special needs in our target services or are interested in learning more about our company, please feel free to contact us for more details.
Frequently Asked Questions
Q. What are the applications of the bioburden testing?
A. It can be used for raw material testing, quality control of pharmaceutical water, process testing of drugs, process water testing, the food and beverage industry, and medical equipment.
Q. What variables affect recovery?
A. 1. The colony forming units or "CFU" are not true cell count, 2. incubation conditions, 3. Nutrition requirement, 4. Physical condition, 5. Dilution errors, 6. When environmental organisms are in an exponential growth phase, they are unlikely to recover.
For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.
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