Testing Services

Accredited microbial testing for USP <797> compliance — from cleanroom environmental monitoring to media fill kit analysis.

Taylor Lake Laboratories

All Taylor Lake Laboratories services are performed under our A2LA accreditation (Cert. No. 7533.01) to ISO/IEC 17025:2017. Our accredited scope covers microbial enumeration, microbial identification, and media fill kit analysis on samples from cleanroom environments — tested to USP <797> and our validated standard operating procedures.

Accredited Service

Environmental Monitoring

Routine environmental monitoring (EM) is a core requirement of USP <797> for sterile compounding facilities. Taylor Lake Laboratories provides accredited analysis of air and surface samples collected from your ISO-classified cleanroom environments.

  • Air Sampling — Viable particle counts from ISO 5, 7, and 8 environments using active air samplers
  • Surface Sampling — Contact plate and swab analysis from critical and controlled areas
  • Microbial Enumeration — Colony-forming unit (CFU) counts performed to USP <797> action level thresholds
  • Microbial Identification — Microscopy and biochemical testing to identify organisms to genus/species level
  • ISO 17025 Reports — Accredited test reports suitable for regulatory inspection and accreditation review
Environmental monitoring in a pharmaceutical cleanroom
Accredited Service

Personnel Monitoring

USP <797> requires regular assessment of personnel aseptic technique through gloved-fingertip and thumb sampling. Our accredited testing helps verify that your compounding staff meets contamination control requirements.

  • Gloved-Fingertip Sampling (GFTS) — Analysis of both-hand, all-finger contact plate impressions
  • Thumb Sampling — Included per USP <797> requirements for initial and re-qualification
  • CFU Enumeration — Counts reported against USP <797> specified action levels (≤3 CFU for Category 1; ≤1 CFU for Category 2)
  • Organism Identification — Identification of any growth to support investigation and corrective action
Personnel monitoring and gloved-fingertip testing
Accredited Service

Media Fill Kit Analysis

Media fill testing is a critical tool for demonstrating that your aseptic technique and compounding process does not introduce contamination. Taylor Lake Laboratories provides accredited incubation and analysis of media fill units prepared at your facility.

  • Media Fill Unit Incubation — Performed under controlled conditions per USP <797> and our validated SOP
  • Contamination Assessment — Visual and analytical assessment at required incubation intervals
  • Documented Results — Accredited reports issued for each media fill lot analyzed
Media fill kit analysis
Expanding Capabilities

Expanding Capabilities

We're continuously growing to meet the evolving needs of our clients. Here's what's on the roadmap.

Coming Soon

Water Testing

Pharmaceutical water quality testing — including purified water and water for injection — to support your cleanroom and compounding operations.

In Development

Mold Testing

Fungal and mold identification services to expand your environmental monitoring program beyond bacterial contamination.

Coming Soon

Monthly Viable Sampling Kits

Mail-in monthly viable sampling kits to simplify your routine environmental monitoring program — everything you need in one shipment, delivered to your facility.

Logistics

Flexible Sample Submission

We make sample delivery easy regardless of your location.

Shipping

Pre-labeled shipping materials are provided so you can send samples directly to our Webster, TX laboratory with no logistical guesswork. Kits are configured to maintain sample integrity in transit.

  • Shipping labels provided for all clients
  • Out-of-state shipments accepted
  • Saturday shipping available upon request

Local Drop-Off

Houston-area clients and technicians can drop samples directly at our Webster, TX facility. Special arrangements for Saturday drop-offs are available — just contact us in advance.

  • Direct drop-off at 1425 Atlantis Dr., Ste C, Webster, TX
  • Houston technician drop-off supported
  • Saturday drop-offs by arrangement

Ready to Schedule Your Testing?

Contact us today to discuss your USP <797> testing needs, get a quote, or learn more about our sample submission process.