Berkshire’s Guide to properly fold and use a low-linting wiper for maximum efficiency and effectiveness in a controlled environment. Download our Cleanroom Proper Wiper Folding and Surface Cleaning Poster Today! Shop our Cleanroom Wipes
Introduction Pharmaceutical and medical device manufacturing personnel must cope with endotoxins – a contamination source unique to their industries. Endotoxins, also known as pyrogens, originate from dead (!) gram negative bacteria. When this strain of bacteria are killed by antibacterial reagents (say phenolic or quaternary ammonium compounds), radiation, steam sterilization, etc. the cell wall detritus [Read More…]
The EasyClean® 360 is the most efficient way to clean a laminar flow hood. It’s unique triangular shaped head allows it to clean the difficult tight corners in the hood. The tool is delivered with two handles, a 14” (35cm) and 24” (61cm). There is also another ordering option for a telescoping handle that will extend from 35 [Read More…]
ISO Class 5 – Primary Engineering Controls (PECs) LAFWs – BSCs – CAIs – CACIs At the beginning of the each shift Before each batch No longer that 30 minutes after previous disinfection (during ongoing compounding) After spills When a surface contaminate is known or suspected Clean area after surface sampling (i.e. Contact Rodac Agar [Read More…]
Q: What is the Best Food Contact Surface Wipe? A: The best food contact compliant surface wipe must be tested by a third party lab for compliance with FDA 21 CFR regulations. The following Berkshire wipes have been tested and are compliant, written test results can be provided upon request.
AAMI is the Association for the Advancement of Medical Instrumentation. Berkshire’s line of Gamma Wipe® cleanroom wipes are gamma irradiated and validated sterile to a 10-6 Sterility Assurance Level (SAL) per AAMI guidelines. Did you know? – The International Organization for Standardization (ISO) defines Sterility Assurance Level (SAL) as the “probability of a single microorganism occurring on an [Read More…]
Although it may seem like longer, it was just two short months ago that we welcomed in a new year, one full of promise for exciting developments in the contamination control industry. And it’s off to a flying start. Already in February, as we were still reeling from the issues with Tri-Coast Pharmacy(1), came not [Read More…]
Is the validation process the same for sterile presaturated vs. sterile dry wipers? Yes, the validation process is the same for presaturated vs. dry as they both follow ANSI/AAMI/ISO 11137, Sterilization of Health Care Products. The product is saturated, packaging is sealed and then the cases are sent to be irradiated. The cases are irradiated wet. [Read More…]
Gamma Irradiated refers to a product that has been irradiated at some predetermined dose which is felt to kill the bioburden. Sterility testing is usually not performed nor quarterly audits for continued validation. The Sterility Assurance Level (SAL) cannot be predicted. A higher dose of radiation may be delivered to the product than may not [Read More…]
In contamination control, there are generally two types of contamination problems: complex problems that even those who are dedicated to cleaning out sometimes miss, and outright negligence. Sometimes, an issue as simple as not knowing the proper contamination control procedures can lead to contamination that gets the FDA on you. That was the case recently [Read More…]
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