Hygiene & monitoring plans
Creation and implementation – matched to your rooms and processes.
Industry · Cleanroom Laboratories
Operating cleanroom laboratories safely and audit-proof.
Hygiene, monitoring, qualification and documentation – we integrate your cleanroom processes in a GMP-compliant and secure way into your quality management.
Requirements
Sensitive processes, high standards.
Cleanrooms are subject to particularly strict requirements – for technology, environment and documentation:
- Hygiene & behaviour – clear rules for personnel and materials.
- Seamless monitoring of particles, microbes and climate.
- Qualified rooms & equipment with documented evidence.
- Audit-ready documentation for authorities and customers.
Services
Our consulting focus in the cleanroom.
Qualification
Rooms, equipment and processes to DQ, IQ, OQ and PQ – traceably documented.
Validation
Validate manufacturing and testing steps – secure in inspection and requalification.
QM system integration
Embed cleanroom processes seamlessly into your system to ISO 9001 and the GMP guide.
Personnel training
Behaviour in the cleanroom and GMP requirements – taught in a practical way.
Audits & reviews
Internal audits, deviation management and quality management reviews.
Approach
Structured towards a verifiable routine.
- StocktakingAssess rooms, processes and documentation in their current state.
- Concept & plansDefine the hygiene, monitoring and qualification concept.
- ImplementationQualify, validate and document.
- Training & routineEnable personnel and secure routine operation.
Consultation
Let's talk about your laboratory.
From qualification to a lived routine – we make your cleanroom processes verifiable.