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Oct. 27-28, 2025, Boston, MA, USA - Booth 114.
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Microbial Limit Testing

Microbial Limit Testing

BOC Sciences' microbial limit testing services deliver comprehensive solutions for detecting, enumerating, and monitoring bacteria, yeasts, molds, and specified pathogenic microorganisms in pharmaceutical, biotechnology, and chemical products. Our services support raw material screening, in-process contamination control, and finished product quality assessment. Using validated techniques, including membrane filtration, plate count, most probable number, and rapid microbial methods, our workflow covers sample receipt, preparation, analysis, and detailed reporting. By combining high-sensitivity analytical platforms with flexible, client-tailored approaches, BOC Sciences provides accurate, reproducible microbial data that optimizes manufacturing processes, mitigates contamination risks, ensures consistent product quality, and supports informed quality assurance and product release decisions.

Microbial Limit Testing Service Portfolio at BOC Sciences

Microbial Enumeration Testing

At BOC Sciences, we perform total aerobic microbial and yeast/mold counts using standardized methods, including membrane filtration, pour plate, and spread plate techniques. Our testing ensures accurate quantification, helping you monitor microbial levels and maintain product safety and quality compliance.

Specified Microorganism Testing

We detect critical pathogens such as E. coli, S. aureus, Salmonella, P. aeruginosa, and C. albicans. Our targeted microbial testing provides reliable results to safeguard your products, mitigate contamination risks, and ensure consistent quality.

Method Suitability Testing

Our team validates microbial testing methods to confirm they are suitable for your product matrices. By accounting for potential preservative interference, we ensure accurate recovery of microorganisms, providing confidence in your testing data and product safety evaluation.

Bioburden Testing

BOC Sciences offers comprehensive bioburden assessments to evaluate total microbial load in raw materials and finished products. Our analysis supports process control, identifies contamination risks, and ensures products meet strict quality and manufacturing standards.

Rapid Microbial Screening

We provide accelerated microbial screening using optimized techniques to quickly detect contamination. This service enables timely decision-making during production, minimizes batch risk, and ensures your product remains compliant with internal and customer-driven quality expectations.

Customized Microbial Testing Programs

We design tailored microbial limit testing solutions to meet specific product types, industry standards, and client requirements. Our flexible approach integrates multiple methods to deliver actionable results, supporting quality assurance, risk management, and product release.

Need Reliable Microbial Limit Testing for Quality Assurance?

BOC Sciences provides precise, reproducible microbial-limit-testing results, helping you control contamination risks and maintain consistent product quality.

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Methods for Microbial Limit Testing

MTT Assay

Membrane Filtration (MF) Method

Combining filtration and culture techniques, the Membrane Filtration Method captures microorganisms on a filter and grows them on selective media. This method enables precise detection of microbial presence in clear liquids, reduces interference from inhibitory substances, and provides reliable microbial counts in a single test.

CCK-8 Assay

Plate Count Method

Integrating sample dilution with plate culture, the Plate Count Method allows enumeration of microbial colonies directly on agar surfaces or within poured media. This approach delivers accurate colony counts and visual confirmation of microbial growth, streamlining routine quality control testing.

Caspase-3 Activity Assay

Most Probable Number (MPN) Method

Using statistical dilution and liquid culture, the Most Probable Number Method estimates microbial concentration for low-level or heterogeneous samples. By combining quantitative estimation with observable growth patterns, it provides sensitive detection in challenging sample matrices without requiring direct colony counting.

LDH Assay

Rapid Microbial Methods (RMM)

Rapid Microbial Methods leverage optical, luminescent, or molecular techniques to detect microorganisms quickly. By providing both presence/absence data and quantitative estimates in a shortened timeframe, they accelerate quality assessment and reduce reliance on time-consuming traditional methods.

Samples Range of Microorganisms for Our Testing

BOC Sciences provides comprehensive microbial detection covering a wide spectrum of indicator, pathogenic, and fungal species to support product safety, quality, and process control.

Indicator Microorganisms

  • Escherichia coli
  • Coliforms
  • Bile-tolerant Gram-negative bacteria
  • Enterobacter spp.
  • Klebsiella spp.
  • Enterococcus faecalis

Specified (Pathogenic) Microorganisms

  • Salmonella spp.
  • Staphylococcus aureus
  • Pseudomonas aeruginosa
  • Candida albicans
  • Clostridia spp.
  • Shigella spp.
  • Listeria monocytogenes

Common Fungi and Yeasts

  • Aspergillus niger
  • Penicillium spp.
  • Saccharomyces cerevisiae
  • Candida glabrata
  • Fusarium spp.
  • Rhizopus spp.

Microbial Limit Testing – Sample Submission Form

Share your sample information and requirements, and BOC Sciences will provide tailored testing advice and actionable results.

Submit Your Sample

BOC Sciences Microbial Limit Testing Workflow

Requirement Understanding

1Initial Consultation and Requirement Assessment

Clients provide sample details and testing objectives. Our specialists discuss goals and design a tailored microbial testing plan.

Experimental Design

2Sample Receipt and Preparation

Samples are received, logged, and processed under controlled conditions. Preparation ensures accurate and reliable microbial analysis results.

Model System Construction

3Microbial Analysis and Monitoring

Comprehensive microbial testing is conducted using validated methods. Results are continuously monitored and documented for accuracy.

Pharmacological Testing Execution

4Data Review and Report Delivery

Findings are analyzed and compiled into a clear report. Final results are delivered to clients promptly.

Flexible Microbial Solutions for Pharmaceutical Applications

01

Solution for Pharmaceutical Manufacturers

BOC Sciences offers comprehensive microbial limit testing tailored to pharmaceutical manufacturers, covering raw materials, intermediates, and final products. We deliver accurate microbial enumeration and contamination detection, ensuring quality control and compliance with industry standards for drug production.

02

Solution for Biotech Startups

For emerging biotech companies, BOC Sciences provides flexible microbial limit testing services that support early-stage formulation and process development. Our rapid, sensitive analysis helps startups identify contamination risks and optimize microbial safety during drug development.

03

Solution for Contract Research Organizations (CROs)

BOC Sciences collaborates with CROs to deliver customized microbial limit testing solutions. We provide high-throughput, reproducible analysis for diverse sample matrices, supporting clients in outsourced drug testing projects with reliable, standardized results.

04

Solution for API Suppliers

API suppliers benefit from BOC Sciences targeted microbial limit testing services for raw materials and intermediates. Our precise testing identifies and quantifies microbial presence, helping suppliers ensure product consistency, minimize contamination risk, and support downstream drug manufacturing.

Start Your Microbial Limit Testing Project Today!

Contact BOC Sciences to initiate your microbial-limit-testing services. Our experts provide accurate, reproducible microbial analysis for raw materials, intermediates, and finished products, helping you control contamination risks and ensure consistent product quality.

Request a Quote

Distinct Advantages of Our Microbial Limit Testing Service

Comprehensive Microbial Detection Capability

Our service detects bacteria, fungi, yeasts, and spores using plate count, membrane filtration, and rapid microbial methods for thorough contamination assessment.

High-Sensitivity Analytical Systems

With advanced imaging and automated colony counting platforms, we deliver reliable low-level detection and enhanced accuracy across complex sample types.

Standardized yet Flexible Testing Workflow

Validated protocols and intelligent sample management ensure consistency while enabling flexible adaptation to varied project scales and testing requirements.

Efficient Reporting and Data Integrity

Automated incubation monitoring and digital reporting accelerate turnaround while ensuring data authenticity, completeness, and full traceability throughout testing.

Applications of Our Microbial Limit Testing

Analytical Testing and Release

  • API Sterility Assessment
  • Raw Material Microbial Check
  • In-Process Contamination Monitoring
  • Finished Product Safety Evaluation

Formulation Services

  • Excipient Microbial Screening
  • Pre-Formulation Contamination Control
  • Stability Study Microbial Analysis
  • Soft gel & Oral Solid Dose Testing

Small Molecule (API) Development

  • Lead Compound Contamination Check
  • Impurity & By-product Microbial Analysis
  • Batch Consistency Microbial Testing
  • Risk Assessment for New Molecules

Microbial Limit Testing Case Studies and Success Stories

Client Needs: A pharmaceutical company developing small-molecule injectable solutions required microbial limit testing to ensure batch safety and consistency before preclinical studies.

Challenges: The client faced variability in microbial counts due to complex excipient matrices, creating uncertainty in batch quality and delaying formulation validation.

Solution: BOC Sciences implemented a tailored microbial limit testing workflow combining membrane filtration and plate count methods with validated neutralization protocols. Multiple replicates and internal controls ensured reproducibility and accuracy.

Outcome: Delivered precise microbial counts across all batches, enabling the client to identify and mitigate contamination sources. This ensured formulation consistency and supported efficient preclinical evaluation.

Client Needs: A biopharmaceutical company developing lyophilized protein therapeutics required microbial limit assessment to confirm sterility and stability post-lyophilization.

Challenges: The client experienced inconsistent microbial recovery due to high sugar excipient content, complicating sterility assurance and batch comparison.

Solution: BOC Sciences applied optimized dilution, resuspension, and plating techniques suitable for lyophilized matrices, combined with quality control checks to ensure accurate detection.

Outcome: Provided reproducible microbial limit data, enabling the client to confirm batch consistency, optimize formulation processes, and maintain product quality throughout development.

Client Needs: A pharmaceutical company developing topical creams and gels required microbial limit testing to evaluate contamination risk and ensure consistent microbial quality across formulations.

Challenges: The client faced interference from high-viscosity excipients, which hindered microbial recovery and made comparative evaluation across batches unreliable.

Solution: BOC Sciences implemented customized sample preparation with neutralizing agents and homogenization, combined with standard plate count and enrichment techniques to ensure accurate results.

Outcome: Delivered reliable microbial limit data across all topical formulations, allowing the client to identify contamination risks, optimize manufacturing procedures, and ensure product safety and consistency.

Frequently Asked Questions

Frequently Asked Questions

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