Water is one of the most widely-used ingredients in any cleaning solution. With the proper additives, water is an effective cleanser. However, in critical manufacturing, it is important to know that all water is different (even tap water in two different locations.) The quality of water directly impacts the quality of your product. Therefore, you […]
Month: July 2014
Checklist of Considerations for Pharma Cleanroom Design: Part Two
Last week, we began summarizing the main points of Tim Sandle, PhD’s article in Controlled Environments. His article provides a close look at what needs to be considered when building a pharmaceutical cleanroom. At the end, we provided a link to a full article on validation master plans, as one requires full comprehension of this […]
Checklist of Considerations for Pharma Cleanroom Design: Part One
Contamination control in a cleanroom is reliant upon a number of factors. Pharmaceutical grade cleanrooms have a few more factors than some other controlled environments. There are a number of standard considerations in pharma cleanroom design to control contamination caused by the combination of airflow, sources of heat, and any objects present. Tim Sandle, […]
USP 797 Compliance: Creating a Cleaning Standard Operating Procedure (SOP)
If you’re maintaining a USP 797 compliant cleanroom, you’re required to have written cleaning STandard Operating Procedures (SOPs) and cleaning logs. Your SOP should include when to clean, how to clean, and what to clean with. Here are some guidelines on these categories. How Often? Surfaces of sterile compounding areas need to be cleaned with […]