Critical environment cleaning, now entering life sciences.
AMCORN's IoT monitoring and compliance documentation platform is expanding into GMP-regulated pharmaceutical cleanrooms, biotech research facilities, and medical device manufacturing environments. Assessment programme open now.
The gap in the market
GMP cleanrooms are cleaned by generalists. That is the problem.
Pharmaceutical and biotech facilities operating under EU GMP Annex 1 and ISO 14644 require cleaning to be performed to a written, version-controlled protocol. The work must be documented to batch record standard, evidenced with pre and post particle counts, and carried out by operatives whose competency is formally assessed. The regulatory requirement is explicit. The available supply of cleaning providers who genuinely meet it is not.
Most pharmaceutical sites either rely on in-house cleaning teams without independent certification, or contract generalist FM companies who list pharmaceutical cleaning as a service without the underpinning QMS integration, operative qualification framework, or real-time environmental monitoring that a MHRA inspection actually requires. AMCORN is building the specialist alternative.
The platform, applied to life sciences
The same technology. A new compliance layer.
IoT Environmental Monitoring
Particulate counters, temperature, humidity, and differential pressure sensors are installed in your cleanroom and report continuously into your AMCORN portal. You get real-time data between scheduled cleans. A threshold breach triggers automatic intervention dispatch.
GMP-Structured Documentation
Every clean produces a completed batch record: operative ID, time, particle counts by zone, chemical lot numbers, deviations noted. Delivered digitally within 2 hours of clean completion. Formatted for your site master file and MHRA inspection readiness.
Protocol-Driven Operative Model
Operatives trained and assessed against a written competency framework aligned to EU GMP Annex 1. Site-specific Written Cleaning Protocols reviewed with your QA team before first clean. Qualification records provided before any operative enters your controlled area.
Target environments
Built for GMP-regulated facilities
Assessment programme
We are onboarding assessment clients now.
AMCORN's life sciences cleaning programme launches in H2 2026. We are currently conducting Cleanroom Readiness Audits. Each audit is a 4-hour site assessment that benchmarks your current cleaning operation against ISO 14644 and GMP Annex 1 requirements and produces a written gap analysis. Audit clients who proceed to a cleaning contract receive the audit fee credited against their first programme invoice.
Request a Cleanroom Readiness AuditAudit fee: £950. Credited in full against first programme contract.
Cleanroom Readiness Audit
4-hour site assessment. Written gap analysis against ISO 14644 and GMP Annex 1. Delivered within 5 working days.
Protocol Development
Site-specific Written Cleaning Protocol drafted with your QA team. Reviewed, approved, version-controlled.
Certified Programme Launch
IoT sensors installed. Operatives qualified. First certified clean completed with full batch record documentation.
Applicable standards
Credentials aligned to controlled environments
Related Services
Raised Floor & Plenum Cleaning
Particulate accumulation in sub-floor plenum spaces is the primary source of heat sink contamination and cooling inefficiency in active data halls. AMCORN deploys HEPA-filtered vacuum systems and ESD-safe equipment, with particle count verification before and after every clean.
Active Equipment Cleaning
Server rack, UPS, PDU, and networking equipment cleaning performed live or during scheduled maintenance windows. AMCORN's ML dispatch engine analyses your facility's sensor data and service history to predict the optimal cleaning interval - before degradation becomes a risk, not after.
CRAC / CRAH Unit Cleaning
Blocked cooling coils are a leading cause of unplanned thermal events. AMCORN cleans coils, drain pans, and airflow paths to restore rated thermal performance - and installs temperature and humidity sensors to monitor cooling efficiency continuously between cleans.
Ready to assess your cleanroom?
Tell us about your facility. We respond within one business day with a proposed audit scope. No obligation.
Request Assessment