Expertise.
Cleanroom qualification and management.
Ensure controlled environmental conditions for implants, injections and other sensitive products.
Reliable?
Are your cleanroom processes designed to prevent contamination and production downtime?
Compliant?
Do you already meet all GMP and ISO 14644 requirements for the construction and operation of your cleanrooms?
Efficient?
Do you use modern monitoring and qualification processes to permanently reduce effort and costs?
Cleanroom solutions for regulated production-
environments.
We ensure that your cleanrooms comply with GMP and ISO specifications - from planning to monitoring.
A well thought-out cleanroom concept is the basis for contamination-free processes. Whether it's a new project or a conversion - we plan the layout, air routing and zone classification to suit your production requirements and consistently implement the regulatory requirements of GMP and ISO 14644.
Our consultants take care of the entire qualification process, including particle and germ measurements and documentation for audits. We optimize existing systems with smart sensor technology, data integration and clear routines.
This ensures that even the most sensitive products - such as injection solutions, sterile packaging or implants - are manufactured under stable conditions and in an audit-compliant manner at all times.
Ensure quality, compliance and efficiency in your cleanroom environment.
Cleanroom qualification and management - Safe operation for critical products.
Our solutions ensure that you can reliably plan, operate and monitor cleanrooms in accordance with GMP and ISO 14644:
Cleanroom planning and classification.
- Design concept based on product requirements
- Selecting the right cleanroom class
- Integration into your existing infrastructure
Qualification procedure and documentation.
- IQ/OQ/PQ according to GMP and ISO 14644
- Proof of performance under practical conditions
- Preparation of all necessary documents
Monitoring and hygiene controls.
- Particle counting and germ monitoring in real time
- Alarm functions and trend analyses
- Link with QMS and batch release processes
Case studies - Successful cleanroom solutions from the field.
From planning new zones to optimizing existing facilities - our projects show how safe cleanroom conditions are implemented in regulated industries.
Establishment of a GMP clean room for implant production
Optimization of an existing clean room in the pharmaceutical industry
Clean room validation for injection processes
Challenge.
A medical technology manufacturer required a validated class B cleanroom for implant production.Measures.
- Planning and construction of a clean room with optimized air flow
- Carrying out OQ and PQ including particle and germ tests
- Complete GMP-compliant documentation for regulatory audits
Results.
- Stable compliance with class B according to GMP
- Reduced risk of contamination and clean production environment
- Audits successfully passed
Success.
Market access for high-quality implants through validated processes and tested cleanroom conditions.Guarantee product purity and regulatory safety with our cleanroom expertise.
Our cleanroom service according to GMP/ISO.
We offer comprehensive solutions for the planning, qualification and operation of cleanrooms in regulated industries such as pharmaceuticals and medical technology.
From initial concept development to implementation, we support you in creating customized cleanroom concepts that meet the requirements of GMP and ISO 14644.
We carry out all phases of qualification - Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) - and document them in accordance with current regulatory requirements.
Our service includes the implementation of continuous monitoring systems to monitor critical parameters and the regular requalification of your cleanrooms to ensure compliance with cleanliness classes in the long term.
We offer training for your staff in the use of cleanroom technology and provide support in optimizing processes to increase efficiency and compliance.
Ensure the purity of your processes right from the start.
Related topics - Your next steps towards clean and safe production.
Whether pharmaceuticals, medical technology or biotechnology - these services complement your cleanroom strategy in technical, regulatory and process terms.