Microbial Testing Services for Cleanrooms and Controlled Environments

We deliver audit-ready microbial testing services that prove your cleanrooms, sterile compounding areas, and controlled environments meet regulatory standards. As one of the few laboratories in the nation with A2LA accreditation for environmental monitoring, we provide the defensible documentation quality assurance professionals rely on.

Our microbial testing services identify and quantify bacteria, fungal, and other contamination in pharmaceutical facilities, compounding pharmacies, healthcare institutions, and manufacturing operations nationwide. [1] From routine environmental monitoring to urgent pre-audit verification, we combine technical precision with fast turnaround times that match your compliance deadlines.

What makes us different: documented chain of custody from collection to analysis, color-coded reporting that makes vulnerabilities immediately visible, and comprehensive certificates that include organism type, count, and location.

Since 1976, Allometrics has helped quality assurance managers pass inspections and operations directors maintain continuous compliance. When contamination control verification can’t fail, trust the laboratory that built its reputation on measurement certainty.

Comprehensive Microbial Testing Capabilities

Bacterial Contamination Detection

We identify and quantify the most common bacterial contaminants found in pharmaceutical and healthcare environments, including:

  • Staphylococcus, Staphylococcus aureus & Coagulase-negative Staphylococcus
  • Pseudomonas aeruginosa
  • Bacillus species
  • E. coli & Enterococcus
  • Streptococcus species
  • Micrococcus
  • Corynebacterium
  • Stenotrophomonas
Bacterial and Fungal Sampling
Allometrics’ extensive experience allows us to provide our clients with the most advanced microbial testing services for various sample matrices.

Fungal Analysis

Our laboratory detects problematic fungal contamination including:

  • Aspergillus 
  • Penicillium
  • Cladosporium
  • Alternaria 
  • Curvularia
  • Stachybotrys
  • Chaetomium
  • Yeast organisms

Testing Methods We Perform

  • Air Sampling
  • Surface Sampling
  • Gloved fingertip sampling
  • Media Fill Testing

Clear, Color-Coded Reporting

Our comprehensive reports use color-coding to help you identify contamination risks at a glance:

  • Green: No growth detected (passing)
  • Blue: Organisms present within acceptable limits (passing)
  • Red: Out-of-compliance counts requiring action (failing)
  • White: Results non-applicable to USP 

Each report documents sample locations, organism types and counts, incubation temperatures, plate types used, and applicable guidelines—giving you everything auditors need to verify your environmental monitoring program.

Other Testing Available: Don’t see your specific organism of concern or testing method listed? Contact our laboratory team at (281) 474-3329 to discuss microbial testing tailored to your contamination control needs.

Industries We Serve

Our microbial testing services support organizations where contamination control directly impacts product safety, patient outcomes, and regulatory compliance:

Pharmaceutical & Compounding

  • Sterile compounding pharmacies preparing IV medications
  • Hospital pharmacies with cleanroom operations
  • Radiopharmacies handling radioactive compounds
  • Oncology clinics compounding hazardous drugs
  • Independent compounding facilities serving multiple healthcare providers

Healthcare & Medical

  • Hospital operating rooms and surgical suites
  • Laboratory facilities processing diagnostic samples
  • Medical device manufacturing cleanrooms
  • Tissue banks and cell therapy centers
  • Dental clinics with sterile processing areas
The Many Benefits of Cleanroom Certification
Research and Pharmaceutical Compounding

Research & Education

  • University research laboratories with biosafety requirements
  • Independent research facilities conducting microbiology studies
  • Colleges with pharmacy and medical technology programs
  • Contract research organizations (CROs) serving pharmaceutical clients

Manufacturing & Processing

  • Food processing facilities requiring environmental monitoring [2]
  • Biotechnology companies producing biological products
  • Cosmetics manufacturers with cleanroom operations
  • Nutraceutical producers following GMP requirements

Each industry faces unique contamination risks and regulatory requirements. Our testing protocols adapt to your specific standards whether you follow FDA guidance, state board of pharmacy regulations, or ISO cleanroom classifications.

Why Quality Assurance Professionals Trust Allometrics

A2LA ISO 17025 Accreditation You Can Defend

Independent auditors have verified our laboratory competence, quality systems, and measurement traceability. Our accreditation scope specifically covers environmental monitoring—giving you results that withstand regulatory scrutiny.

50+ Years of Regulatory Expertise

Since 1976, we’ve supported clients through FDA inspections, state board surveys, and accreditation audits. We stay current with USP chapter revisions and regulatory guidance so your testing remains compliant.

Nationwide Laboratory Service

Our Webster, Texas facility serves clients across the United States. We provide complete sample collection kits with detailed instructions and onsite testing by our experienced technicians. 

Visual Reporting That Simplifies Compliance

Our color-coded reports eliminate guesswork. Green, blue, red, and white indicators let you spot contamination issues instantly without decoding complex data tables. Each report documents sample locations, organism identification & count—presented in a format that busy quality assurance professionals can review quickly and auditors can verify easily.

Our Microbial Testing Process

What is Microbial Testing?

Microbial testing verifies that your controlled environments remain free from harmful levels of microbial contamination, be it bacteria, fungi or something else. Regulatory agencies require this testing to prove your cleanrooms, sterile compounding areas, and processing environments meet contamination control standards that protect product quality and patient safety.

The process involves collecting samples from air, surfaces, or personnel, then culturing those samples in our laboratory under controlled conditions. Microorganisms present in the sample grow into visible colonies that we count, identify, and compare against your acceptance criteria.

Why Regular Microbial Testing Protects Your Operation

Protects Patient Safety and Product Integrity

Proactive environmental monitoring prevents harmful bacteria, mold, and fungi from contaminating sterile products that could cause severe patient illness. Regular testing catches contamination before it reaches finished goods, protecting both patients and your product reputation.

Reduces Waste and Prevents Recalls

Detecting contamination early eliminates the waste of raw materials, labor, and production time. Routine monitoring identifies problems at the source—HVAC systems, cleaning procedures, personnel technique—before entire batches require destruction or costly market recalls.

Validates Your Contamination Control

Testing verifies that HEPA filters work, cleaning procedures eliminate organisms, and personnel technique maintains sterility. It’s objective proof your systems perform as designed.

Qualifies Personnel Competency

Glove sampling demonstrates that staff maintain aseptic technique during critical operations—required evidence for USP compliance and personnel training programs.

Comprehensive Reporting
Monthly Surface Sampling Why It’s Needed

Risks of Inadequate Environmental Monitoring

Regulatory Consequences

Missing or insufficient microbial testing data creates immediate audit findings. FDA warning letters frequently cite inadequate environmental monitoring programs. State boards can restrict compounding privileges until deficiencies are corrected.

Reputation Damage

Contamination events that reach patients trigger mandatory reporting, public notifications, and permanent records in FDA databases. The reputational cost extends far beyond immediate financial losses.

Blind Spots Create Crisis Response

Facilities without routine monitoring only discover contamination through failed product testing or patient adverse events—forcing expensive emergency investigations when proactive testing would have provided early warning and simple corrective action.

Schedule Your Microbial Testing Service

Get audit-ready results from an A2LA ISO 17025 accredited laboratory with 50+ years serving regulated industries.

USP Cleanroom Compliance Service Provider - Allometrics Inc

Whether you need routine environmental monitoring, pre-audit verification testing, or urgent contamination investigation support, our team executes your sampling protocols with the precision and documentation quality that regulators expect.

Nationwide laboratory service from our Webster, Texas facility—complete sample collection kits with detailed instructions or onsite collection and excellent technical support when you need clarification on results or regulatory requirements.

Call (281) 474-3329 to discuss your testing schedule and receive a detailed quote. 

Let us show you why quality assurance professionals trust Allometrics for microbial testing that protects their products, their patients, and their compliance records.