When you think of a pharmaceutical or medical device company, cleanliness comes to mind when production comes to mind. Cleanrooms are a necessity when it comes to a company’s production area. What is a cleanroom exactly? A cleanroom is a controlled environment used in manufacturing with a low level of pollutants, such as airborne microbes, dust, and aerosol particles. Pharmaceutical and medical device companies follow specific regulatory standards, primarily following the ISO 14644-1:2015 guidelines. Your company must follow different rules and regulations depending on the product being manufactured. Before production can begin, you must determine what type of cleanroom it is and then have the cleanroom qualified for use. For this example, a medical device company has a cleanroom that needs to be put into production. Let’s go through the steps you must take to get your cleanroom ready for business.

How to initiate a cleanroom

First, you need to determine what room classification the cleanroom needs. The classification is a guideline for how many particulates are acceptable for the manufactured product within the room. Once you have determined the cleanroom classification, you can assemble the appropriate documents such as standard operating procedures, room qualification, and testing forms. The SOPs address how the cleanroom will be used, qualified and cleaned. Qualification tests the room’s controlled aspects to ensure it is acting as it should. Finally, you create the forms to report the findings of cleaning and environmental monitoring.

How to test a cleanroom for qualification

Cleanroom testing differs from environmental monitoring because cleanroom testing concentrates on the room performance, not the product contamination risk. When qualifying a cleanroom, you want to test for differential pressure, airflow, temperature mapping, and particle counts in this example for medical devices. Differential pressure measures the pressure within the room and what happens when the main door is open. It will tell you how long it takes for the pressure to go out of range when the door is opened and how long it takes to come back to its range. Airflow will let you know the airflow at each HEPA filter. Particle counts determine the number of particulates in a specific spot in the room. Temperature mapping tests the temperature throughout the room during a 24-hour period. Qualifications can be done in different ways. In this example, testing was done with no one in the room, and when power was shut down in the room to see how long it took for the particle counts to fail and when power was restored. Testing was also conducted with the maximum number of people the room will have during manufacturing.

After testing is completed, all data must be reviewed and within passing specifications for the room to be qualified and ready for use. Depending on your companies’ policies, quality assurance should be the last department to review the qualification for final approval. The qualification must be checked for any deviation that may have occurred, which must be investigated and closed out to be approved.

Get a jump start on cleanroom qualification

Your cleanroom is a vital part of your business and needs to be ready for manufacturing. You want your cleanroom to be prepared and within specification, and if you are not quite sure, let the PSC professional help you along the way. PSC Biotech® can help you in each of these steps – from helping you create documents to performing your qualification and compiling your final report.

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