Cleanroom Qualification for Medical Device Manufacturers – Compliant with Standards, Independent, Audit-Ready.

From initial qualification through ongoing monitoring to annual requalification—a comprehensive service approach covering the entire lifecycle of your cleanroom.

Based on binding standards and guidelines

DIN EN ISO 14644-1, -2, -3 – Classification, testing, evaluation, and monitoring of air cleanliness in cleanrooms
DIN EN 17141 – Biocontamination control, support for the implementation of the Medical Device Regulation (MDR 2017/745)
EU GMP Annex 1 – EU Guidelines on the Manufacture of Sterile Medicinal Products
VDI 2083 Part 3.1 – Guideline for the Evaluation and Monitoring of Cleanrooms

Together, these regulations form the normative framework upon which every cleanroom qualification, monitoring, and requalification is based. All services provided by Normec Hybeta are consistently aligned with these principles.

Regulatory Complexity: Why Cleanroom Operations Require Structured Support

Anyone who manufactures medical devices under controlled cleanroom conditions operates within a demanding regulatory environment. Multiple standards systems—DIN EN ISO 14644, DIN EN 17141, EU GMP Annex 1, and VDI 2083—interlock and must be implemented consistently. Furthermore, many manufacturers lack the personnel resources to ensure compliance-based hygiene monitoring on a long-term basis using their own resources.

The consequences of potential failures are significant:

Production shutdown: Uncontrolledcontamination can bring the entire production process to a standstill—with far-reaching economic and regulatory consequences.
Regulatory non-compliance: Regulatory authorities and auditors require complete, robust documentation. Without independent evidence, there is no basis for operations.
Compromised sterilization efficacy: Insufficiently controlled environmental conditions can lead to increased bioburden and thus affect the effectiveness of sterilization.
Irreversible contamination in aseptic manufacturing: In the aseptic process, there is no downstream sterilization step. Contaminants that have entered the system can no longer be eliminated and therefore pose an immediate risk to product sterility.

Normec Hybeta proactively addresses these risks—with a structured service approach that safeguards the entire cleanroom lifecycle in compliance with standards and embeds regulatory compliance at every stage of production.

The Cleanroom Lifecycle: Three Stages, One Responsible Partner

The qualification of a cleanroom is not a one-time event, but a continuous control loop. Normec Hybeta supports the entire cleanroom cycle and ensures that your process environment remains compliant and safe at all times.

2 Monitoring

Once commissioning is complete, the real test begins: the achieved cleanliness level must be maintained over the long term. Systematic monitoring enables the early identification of deviations, even before they compromise product quality or sterilization success. To obtain reliable trend analyses, the frequency of monitoring is determined on a case-by-case, risk-based basis.

Consulting on the Development of Operator-Side Monitoring
Conducting monitoring
Assistance in the event of irregularities

1 Commissioning (IQ – OQ – PQ)

The approval of a cleanroom for production requires the successful completion of three qualification phases: installation qualification (as-built), functional qualification (at rest), and performance qualification (in operation). Only documentation of all three stages in compliance with standards forms the regulatory basis for production approval.

Consulting on the planning of new cleanrooms
Preparation of User Requirement Specifications
Development of the scope of measurements for each validation phase in accordance with standards

3 Revalidation

Annual requalification by an independent, accredited testing institute provides evidence that the cleanroom environment continues to comply with the documented conditions at the time of initial commissioning. It is the key tool for demonstrating the ongoing compliance of your production environment to regulatory authorities and auditors.

Planning the annual requalification
Conducting the requalification
Assistance in the event of non-conformities

Overview of Services

Technical inspections

in accordance with DIN EN ISO 14644-1, -2, -3

Particle measurement of room air and supply air
Temperature and Relative Humidity
Determination of pressure behavior through flow visualization
Differential pressure measurement
Leak testing of the installed filter system
Recovery time measurement
Supply air flow rate measurement to determine the air change rate
Sound pressure level measurement
Visual inspection of environmental conditions

Microbiological and hygienic testing

in accordance with DIN EN 17141, VDI 2083 Part 3.1, EC GMP Guidelines Annex 1

Airborne microbial count determination by impaction and sedimentation
Surface and contact swab testing
Workplace testing
Morphological differentiation of microorganisms
Sample incubation according to standards or customer specifications

What requirements this entails for manufacturers

Cleanroom qualification as a regulatory requirement: Without standard-compliant qualification, neither production approval nor market authorization for your products can be granted.
Controlled environmental conditions as the foundation of sterilization: Reliable sterilizationsuccess requires a consistently controlled process environment.
Monitoring as a structural requirement: Ongoinghygiene monitoring requires technically qualified personnel. Partnering with an independent institute enhances technical assurance while simultaneously reducing operational workload.
Documentation requirements for auditors and regulatory authorities: Qualification conducted externally by an accredited testing institute provides the evidence base expected during inspections and audits.

Compressed Air and Gas Testing Coming Soon

in accordance with ISO 8573

Normec Hybeta is expanding its accredited range of services to include the systematic testing of compressed air and technical gases—a testing area that is becoming increasingly important from a regulatory standpoint in the cleanroom production of medical devices.

Airborne Microbial Count Determination by Impaction
Endotoxin determination
Total oil content
Pressure dew point (moisture)
Particle count

Would you like to take advantage of this expanded range of services as soon as possible?

We’d be happy to note your interest and will give you priority notification as soon as this service is added to our accredited portfolio.

Why Normec Hybeta Stands Out as a Testing Laboratory

Accreditation according to DIN EN ISO 17025— an internationally recognized proof of competence that enjoys the highest level of acceptance among auditors and regulatory authorities
Structural independence and impartiality— without any financial ties to manufacturers, suppliers, or maintenance companies
A monitoring model tailored to your needs— ranging from training your staff to perform tasks in-house to fully outsourcing the process to Normec Hybeta
Nationwide-recognized test reports – prepared by demonstrably qualified specialists with documented expertise
MALDI-TOF mass spectrometry in our own laboratory— precise, state-of-the-art pathogen identification performed under accredited conditions

In addition: From the process environment to the product:

In addition to cleanroom qualification, Normec Hybeta possesses comprehensive expertise in reprocessing validation for medical devices:

Technical evaluation of product design and reprocessability (material, surface design, durability)
Reprocessing validation in accordance with MDR, DIN EN ISO 17664-1, and ISO 17664-2
Review of manufacturer specifications for practical applicability and regulatory compliance
Material testing and verification of tolerance ranges during repeated reprocessing

In this way, Normec Hybeta combines both dimensions of quality assurance: the controlled process environment (cleanroom) and the validated reprocessing of the product itself.

Additional Service Areas

Are you planning a cleanroom or preparing for your next requalification?

Whether you’re building a new cleanroom, professionalizing your existing monitoring system, or preparing for your annual requalification—involving an accredited testing institute early on reduces the need for adjustments, provides regulatory clarity, and lays a solid foundation for your production.

End-to-End Support—From Planning to Documentation

Normec Hybeta combines technical testing expertise, microbiological analysis, and regulatory know-how into a cohesive service offering. The result: consistently robust documentation that stands up to commissioning, inspections, and audits—without the need for rework and with no room for interpretation.

Your Partner for Quality, Safety, and Compliance

The life sciences sector requires specialized knowledge and reliable support. With our comprehensive expertise, we help companies comply with laws and regulations, ensure quality, and continue to innovate with confidence.