/ PROCESS TEMPO
GMP microbiological testing
Thorough validation of your cleanrooms and HACCP sampling plans to ensure the success of your biomanufacturing audits.
REGULATORY COMPLIANCE
Cutting-edge expertise
Targeted physical interventions to ensure effective control of contamination in your controlled-atmosphere areas.
HACCP
Air & Surfaces
Cleanrooms
Discrepancy Reports
Development of precise microbiological sampling plans and air classification tailored to your routine requirements.
Partial qualification of your cleanrooms with metrological precision that meets GMP requirements.
Analysis of microbiological non-compliance issues and preparation of structured, audit-ready non-conformance reports.
METHODOLOGY
Metrological precision
Our response protocol ensures full traceability and immediate compliance with health standards.
01. Variance Analysis
02. Sampling
03. GMP Deliverables
On-site assessment of critical control points and potential contamination pathways at your facility.
Active and passive microbiological sampling using high-precision, calibrated equipment.
Delivery of a structured analysis and deviation report that can be directly incorporated into your lot file.
QUESTIONS
Technical Responses
How do you handle critical deviations?
What industries do you work with?
We respond within 24 to 48 hours to analyze the discrepancy, identify the root cause, and prepare the regulatory deviation report.
We certify cleanroom environments for the pharmaceutical and biotechnology industries, as well as medical device manufacturers.
Need emergency service or a compliance audit?