cell
entis
Advanced Microbial Identification. Reliable Contract Testing.
Precision Microbial Identification for Regulated Industries
Private Limited
Regulatory Standards
Regulatory Standards & Microbial Identification Requirements
| Sample Source | USP Expectation |
EU GMP Expectation |
Indian Pharmacopoeia (IP) |
Schedule M (India) |
WHO Requirement |
|---|---|---|---|---|---|
| Environmental Monitoring (Air, Surface, Personnel) |
USP <1116> | EU GMP Annex 1 |
IP Sterile Products & Microbiological Monitoring |
Schedule M Environmental Monitoring Requirements |
WHO TRS 1010 Annex 6 |
| Water System Isolates |
USP <1113>, <1231> |
EU GMP Annex 1 |
IP Water for Injection / Purified Water |
Schedule M Water System Monitoring |
WHO GMP Water for Pharmaceutical Use |
| Sterility Test Failure |
USP <71>, <1113> |
EU GMP Annex 1 |
IP 2.2.11 Sterility Test |
Schedule M Investigation Requirements |
WHO Sterility Failure Investigation |
| Media Fill Contaminants |
USP <1113>, <1116> |
EU GMP Annex 1 |
IP Aseptic Process Validation |
Schedule M Sterile Manufacturing |
WHO Sterile Products Guidance |
| Recurrent / Objectionable Organisms |
USP <1113> |
EU GMP Annex 1 CCS |
IP Contamination Investigation Guidance |
Schedule M CAPA & Trending |
WHO Trending & CAPA |
| Product Bioburden / Raw Material Isolates |
USP <1227>, <1113> |
EU GMP Ch.5 & Annex 1 |
IP Microbiological Examination Chapters |
Schedule M In-process Control |
WHO GMP Risk Based Identification |
| EM Alert/Action Limit Excursions |
USP <1116>, <1113> |
EU GMP Annex 1 9.33-9.37 |
IP Microbiological Control Guidance |
Schedule M EM Requirements |
WHO Significant Excursions Investigation |
STORY
What We Do
Microbial identification is a critical part of quality control, contamination investigations, environmental monitoring, sterility-related investigations, and microbiological quality programs.
We combine MALDI-TOF technology with molecular and genetic identification approaches to provide accurate and efficient identification of microorganisms across a wide range of applications.
Honors in research
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Successful studies
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Nations we serve
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Experts on staff
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Microbial Identification
Advanced MALDI-TOF & Genetic Testing
We are a specialized contract testing laboratory providing advanced microbial identification services using MALDI-TOF mass spectrometry and genetic identification technologies.
Our laboratory supports the pharmaceutical, biopharmaceutical, medical device, Cell & Gene therapy & FMCG industries with reliable, science-driven microbial identification solutions designed to help organizations understand, investigate, and control microbial risks throughout their processes and products.
Microbial Identification
Accurate identification using advanced MALDI-TOF and genetic technologies.
Advanced Testing
Reliable laboratory testing with precise and consistent results.
Scientific Expertise
Research-driven solutions backed by modern microbiology techniques
Trusted Results
High-quality contract testing designed to support research and healthcare.
Our Testing Services
Our contract testing services can support
Our Services
Specialized microbial identification and contract testing services powered by advanced technology.
01. MALDI-TOF Mass Spectrometry
Rapid Microbial Identification
Fast and efficient identification of microorganisms based on their unique protein profiles.
02. Genetic Identification
Molecular Microbial Characterization
Genetic testing provides additional characterization when conventional identification requires deeper molecular information.
03. Contract Testing
Specialized Testing Support
Reliable microbial identification services for pharmaceutical, biopharmaceutical, and medical device organizations.
04. Quality & Microbiology Support
Data You Can Rely On
Consistent, scientifically sound, and well-documented results to support routine testing, investigations, and quality workflows.
See what our clients say
Latest news and insights from the industry
Pharma provided accurate results and expert advice for our lab needs. Their team was caring, skilled, and helped us improve patient care outcomes.
Pharma improved our workflow with timely lab results and reliable service. Their experts made a difference in our work with their support and care.
Pharma’s laboratory and research solutions boosted our clinical projects. Their skilled team made a true impact on our progress.
Questions about services
Frequently asked questions