Research Triangle, NC · Cleanroom compliance & facility readiness
Cleanroom testing, stainless care, and CQV — from one local partner.
Quantex Bioservices helps GMP-minded manufacturers keep controlled environments tested, stainless systems maintained, and projects documented — so new suites, expansions, and process changes move toward readiness with fewer handoffs.
- Based in North Carolina
Statewide coverage, primarily on site across the Research Triangle / RTP corridor.
- Field work + documentation
Testing and the records your QA team reviews, from the same partner.
- Standards-referenced methods
Planned with reference to ISO 14644, ASTM A967/A380, ASME BPE, and GAMP 5, as applicable.
- Scoped plainly
Written scope, clear deliverables, no inflated promises.
Services
Four service lines. One readiness record.
Readiness problems often sit between vendors — a test report that doesn't match the protocol, a passivation record no one can find, a system validated against last year's configuration. We bring these lines together so the evidence lines up.
Cleanroom & contamination-control testing
Testing and reporting that support classification, monitoring, and contamination-control decisions.
- HEPA filter integrity testing
- Airflow visualization (smoke studies)
- Particle counting & classification support
- Environmental monitoring program support
Derouging & passivation
Stainless process-system care, planned around your downtime and documented for your quality file.
- Condition assessment & scoping
- Derouging
- Passivation
- Post-treatment records
CQV, engineering & project management
Commissioning, qualification, and validation support sized for small and mid-size projects.
- C&Q planning and IQ/OQ/PQ protocols
- Execution support and turnover packages
- Project and engineering coordination
- Facility readiness reviews
Computer system validation
Risk-based validation support for the systems behind your GMP records.
- Validation planning
- Requirements and risk assessment
- Test protocols and execution
- Data-integrity and Part 11 considerations
The problem we work on
Readiness rarely slips on one big thing.
Testing happens late.
Classification and airflow studies often get scheduled after construction closes out, leaving little room to act on findings before the timeline tightens.
Records don't connect.
Test reports, maintenance records, and qualification protocols arrive from different vendors in different formats — and someone has to reconcile them before QA can sign.
Rigor sized for someone else.
Large-program CQV approaches can overwhelm a small team; ad-hoc approaches leave gaps. The right level of effort depends on the risk, the system, and your quality system.
A clear path from first call to closed-out record.
- Scope
A short conversation about your facility, systems, timeline, and what your quality team needs to see.
- Plan
A written scope, method, and deliverables list, aligned with your SOPs and templates where they exist.
- Execute
On-site testing, maintenance, or protocol execution, with deviations raised as they happen — not after.
- Document & hand over
Reports and records formatted for your QA review and approval, with a clear list of any open items.
Built for teams bringing controlled environments into GMP operation.
We typically support facility, quality, engineering, and validation leads at:
- Small and mid-size biopharmaceutical manufacturers
- Contract development and manufacturing organizations (CDMOs)
- Cell, gene, and other advanced therapy facilities
- Sterile and aseptic manufacturing operations
- University GMP and translational research facilities
- Clinical-stage companies preparing their first GMP suite
Planning a new suite, an expansion, or a recurring test program?
Tell us what you're working on. We'll reply with a few questions, a suggested scope, and next steps.
Request a facility-readiness conversationOr email info@quantexbio.com