Cleanroom cleaning tasks should only be performed by trained personnel and using only cleanroom-certified or cleanroom-approved supplies and solutions. With the cleaning team ready to enter, here is a suggested cleanroom cleaning process: Review Procedures and Protocols: Familiarize yourself with the cleanroom’s cleaning protocols and procedures, as these may vary depending on the class of [Read More…]
Category Archives: Aseptic Cleaning
Without proper cleaning procedures in place, a cleanroom faces several risks. Relying on an informal or as-needed approach to cleanroom cleaning will not protect you, your organization, or your end users and can lead to unnecessary complications. Inadequate cleaning, improper donning, and low-quality supplies can lead to failed quality checks, audits, or even a shutdown. [Read More…]
Whatever contaminates a cleanroom is likely brought into the environment, so it is essential to establish fundamental cleanroom best practices or protocols for the operators. For instance, before anyone enters the cleanroom for cleaning, they should remove personal items (jewelry, keys, phones, etc.) and store them outside the gowning room. If an individual must bring [Read More…]
Your cleanroom is designed to prevent particle entry by filtering and purifying the air, to provide designated areas for different levels of cleanliness, and to isolate spaces with controlled air pressure as required. However, simply having the appearance of a clean room does not ensure its cleanliness. Implementing effective cleanroom cleaning procedures and proper supply [Read More…]
To ensure that the manufacturing of pharmaceuticals is free from contamination, implementing a comprehensive cleaning and disinfection program is essential. Any modifications to the manufacturing process, such as introducing new equipment or materials, should be evaluated to confirm that the cleaning program prevents contamination. Maintaining a standardized change control process to document these updates is [Read More…]
Answer: Berkshire cannot provide specific recommendations regarding how many swipes/passes of a wiper on a surface will make the surface clean or free of microorganisms.The main reason for this is each situation where wipers are used is different and has many variables, each of which will have an impact on the outcome of any cleaning. [Read More…]
Do you clean from top to bottom, left to right, cleanest to dirtiest? There are specific steps involved with cleaning an aseptic isolator. Watch the video for cleaning techniques that can supplement your current SOPs and assist in training.
Do your operators use IPA and Deionized Water on their gloves prior to cleaning a biological safety cabinet? Are they cleaning top to bottom, left to right, cleanest to dirtiest? There are specific steps involved with cleaning a biological safety cabinet. Watch the video for cleaning techniques that can supplement your current SOPs and assist [Read More…]
A low endotoxin cleanroom wipe has a guaranteed endotoxin limit of <20 EU/device – <0.5 EU/mL. This is especially important when you read the FDA Guidance for Industry: Pyrogen and Endotoxins Testing. A 3rd party lab should perform the testing and the testing must be on a lot to lot basis. Printed documentation must be [Read More…]
Question: Has Berkshire or a 3rd party performed any microbial efficacy/kill studies on the SatPax® line of presaturated IPA wipers? Answer: An efficacy/kill study has not been performed by Berkshire or a 3rd party lab for SatPax®. Because of the number of variables involved when using wipes, it would be very difficult to produce meaningful [Read More…]