Negative cleanrooms pose certain challenges when it comes to maintenance and monitoring. Make sure you understand these 4 points ahead of time.
A negative cleanroom has negative air pressure, which means that the outside rooms have a higher pressure. Negative air pressure cleanrooms are often used when hazardous materials are handled. Negative cleanrooms are subject to the same standards and guidelines as any other cleanroom. However, there are limitations to the ASHP required frequency of cleaning and monitoring negative cleanroom facilities. Some areas of concern are:
Cleaning of walls and ceiling at least once a month
Daily cleaning of floors and surfaces
Monitoring tests at least every 6 months to check for nonviable particles
Therefore, anyone who is going to construct one needs to note certain areas in design before, during, and after construction. Here is what you need to know:
Single wall … Read More »
Wipers are necessary to cleaning any cleanroom, but they need to be tested to ensure they’re non-linting. Here is some information as well as good news on testing.
Wiper-based cleaning is one of the most effective methods of cleanroom cleaning. Test data to confirm that wipers are non-linting is a USP 797 requirement. However, there is no recognized test, procedure, or recommended practice that will determine the right wiper for a specific cleanroom, process, or activity. So what do you need to know about finding the right wiper?
There is a recommended practice for determining wiper contamination characteristics, so this is a good place to start. These are found in the IEST-RP-CC004.3, Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments. Here you’ll find descriptions of contamination characteristics and contamination levels like:
Non-speciated extractable matter
In addition to these factors, however, are … Read More »
If you want your employees to think outside the box, shouldn’t you be doing the same? Here’s what a leadership expert has to say.
The strongest leaders know that without innovation, business is doomed. An environment like a cleanroom and the resulting products are in and of themselves innovative. To build on this can mean leaps and bounds for future success.
What do employees need to let their innovative juices flow? Maxine Attong, a seasoned corporate coach with an impressive résumé, offers a suggestion that may surprise you. She attributes the level of an employee’s innovative ideas to how safe he or she feels.
She’s not talking about physical safety.
Attong discusses the importance of feeling safe to express opinions, ideas, and feelings without judgment or repercussion. She says,
“In order to take risks, which is the foundation of innovation and subsequent rewards, a team … Read More »
Part two wraps up the final three phases of the 5-part validation process. Understand the process to validate your cleanroom
In part one, we introduced the first two of five validation phases. Understanding what goes into this complex process will help you better prepare and continue to remain compliant. Each phase revolves around a specific purpose of the validation process. Following Design Qualification and Installation Qualification are:
3. Operation Qualification. This phase proves the cleanroom operates in conformance with both design and user defined requirements. It also shows that the cleanroom consistently operates within a defined range of conditions. Protocol will address:
Testing the HVAC
Critical operating parameters (defined on the room data sheet)
Filter integrity tests
Air flow patterns
The other piece to this phase is to address worst-case scenarios. Worst cases are designed using operation ranges and extreme ranges from … Read More »
Know what goes into the cleanroom validation process so you can best prepare and successfully validate and certify your facility.
Cleanroom control hinges on a number of complex factors. New cleanrooms are validated for a variety of reasons, including:
Ensure the facility’s design is fit for its intended purpose
Ensure the facility, equipment, and environment meet User Requirement Specifications (URS)
Ensure the facility, equipment, and environment meet defined regulatory requirements
Ensure the facility, equipment, and environment function together as a system to meet standards
Validation is accomplished through five phases. Here are the first 2:
1. Design Qualification (DQ). This phase focuses on the first bullet point above, proving the fit through objective evidence. It focuses on URS, vendor documents and specifications, facility layout, POs, design documentation, factory acceptance tests, as build drawings, and data sheets.
The output involves a phase report and Standard Documentation List (SDL) … Read More »