Qualitätswandel offers speedier solution for ISO 14644 Cleanroom Classification

Bresewitz, Germany: – Innovative pharma industry quality management specialists Qualitätswandel Dana Graupner sheds new light on the latest ISO 14644 Cleanroom Classification Standards that are essential for GxP compliance in life sciences production.

A recent Qualitätswandel blog explains that buried deep in the new standards there are speedier methods for determining and evaluating particle concentration in cleanrooms.

ISO 14644 implications for cleanrooms

ISO 14644 defines methods and statistical approaches for determining and evaluating particle concentration in cleanrooms to ensure the necessary quality and safety in the production of sensitive products.

This standard is crucial to ensure the cleanliness and quality of the environment in which pharmaceuticals and medical devices are manufactured. In combination with the EU GMP Guide Annex 1, it forms the basis for the quality standards required in pharma, biotech and medical device manufacturing.

Challenges in cleanroom classification

Typically, the number of sampling locations is determined depending on the room size and the individual sample volume depending on the class limit. For example, for the maximum particle concentration of 3,520 particles per cubic meter demanded for an ISO 5 Cleanroom, the formula A.2 in Annex A of ISO 14644-1 results in an individual testing air sample volume of 5.68 liters. This corresponds to a sampling time of 12 seconds at an airflow rate of 28.3 l/min, comfortably inside the minimum one minute sampling duration required by ISO 14644 at each location, which also determines the minimum time needed to assess the whole clean area.

The picture becomes more challenging in cases where the class particle limit is very small, involving a much larger individual sample volume. For example, to measure down to GMP Class A limit of 20 particles/m³ requires a sample volume of close to 1,000 liters, taking more than 35 minutes at the same flow rate. Assessing a large cleanroom with multiple sampling locations can therefore take an entire day.

The Annex D solution

However, the sequential sampling method described in Annex D of ISO 14644-1 offers a more efficient option. This method is based on comparing accumulated real-time particle counts with reference values. Although this method requires additional data analysis and can be slightly less accurate due to the reduced sample volume, the measurement could be completed in as little as nine minutes, resulting in a time saving of around 75%.

The role of GxP compliance and quality management

Correct cleanroom classification is critical for obtaining and maintaining manufacturing authorization as well as for successful inspection and certification. Compliance with ISO 14644 and the EU GMP Guide Annex 1 is an essential part of quality management. A risk-based approach to validating cleanroom conditions ensures that all regulations are met without compromising product quality.

As GxP consultants for the pharmaceutical and medical device industries, Qualitätswandel brings many years of expertise to bear on quality management issues. It works in partnership with clients to ensure their cleanrooms are classified and validated according to the highest standards. It can also advise on optimizing processes to ensure compliance with all regulatory requirements.

About Qualitätswandel Dana Graupner

Qualitätswandel Dana Graupner GmbH is a quality GMP consultancy and that helps companies, including those in the pharma and life sciences sectors make process transformations that require re-engineered quality management systems.

The company’s ‘Quality Change’ name encapsulates its mission to optimize quality management at organizational and systems levels. The company leverages its deep-rooted GMP and ISO expertise to help clients navigate the highly complex quality assurance landscape and achieve their goals. Its wide-ranging services include developing a GMP quality management system (GMP), ISO 9001 and ISO 13485, process analysis, training and audits.

The company offers customized services highly tailored to the individual needs of pharmaceutical and medical product manufacturers, as well as to clinical and pharmacy organisations, drawing on deep expertise in QM systems, project management, regulatory affairs management, documentation, cleanroom technology, risk assessment, and GAMP 5 CSV Computer Systems Validation.

Founded in 2019 by pharmaceutical quality expert Dana Graupner, Qualitätswandel is based at Bresewitz on Northern Germany’s Mecklenburg-Vorpommern Baltic Coast, with team members located all over Germany and connected online.

In its few years of operation, the company has already conducted scores of successful engagements, currently lists more than 40 client companies, and has been honoured with top consultancy awards for 2023 and 2024.

Resources

Click on Quality Change News: Clean Rooms according to ISO 14644 Classification  for further information (German language).
Click on Help with the Journey to Certification for award profile (German language original).
Click on Qualitätswandel: Your External Partner for Quality Management Systems to learn more (German language).
Click on Advice through Leadership to watch video.