Category Archives: Cleanroom News

What do chickens and cows have in common?

What do chickens and cows have in common

If you answered the bird flu (H5N1) you would be correct. Almost 1,000 dairy herds in 17 states have been infected with bird flu according to data from the U.S. Department of Agriculture. In fact, the U.S. Department of Agriculture since December has been rolling out a nationwide mandatory milk testing program to detect bird [Read More…]

Is there a disinfectant cleared by the FDA and USDA that allows it in organic production and handling?

Is there a disinfectant cleared by the FDA and USDA that allows it in organic production and handling?

Yes, Berkshire’s VersaHOCl®, an EPA-registered stabilized 0.065% Hypochlorous Acid Solution, is an RTU (Ready to Use) one-step cleaner and disinfectant. Hypochlorous Acid (HOCI) has been evaluated by regulatory agencies in more than 50 countries and is cleared by the FDA and USDA as a high-level disinfectant for organic production and handling operations. It is important [Read More…]

The Top 6 Questions for Cleaning Cleanroom Environments

The Top 6 Questions for Cleaning Cleanroom Environments

The importance of cleaning must be balanced in the context of environmental management. Cleanroom maintenance and procedures must be meticulously documented and followed. To establish an effective cleanroom cleaning protocol, the following questions should be addressed: – Which surfaces require cleaning?– What level of cleanliness is necessary?– How will the cleanliness be measured?– What cleaning [Read More…]

FDA Inspections

The Food and Drug Administration (FDA) upholds its commitment to ensuring the safety of our food and medical products. It meticulously inspects both domestic and foreign facilities, utilizing strategic risk-based methods to enforce adherence to federal regulations. These inspections, meticulously guided by risk assessments, are a fundamental component of the FDA’s all-encompassing approach to supervising [Read More…]

Aerospace Wipes by Berkshire

Berkshire Aerospace Wipes

These aircraft wipes are made with the most advanced technology using powerful water jets to weave the fabric together and purify the material. This results in high-performing, ultra-clean, low-lint wipes and towels without any binders, chemicals, or adhesives that could contaminate your work. If you’re looking for quality and high performance, Berkshire aerospace-grade wipes are [Read More…]

The Fundamentals of GMP Cleanroom Classifications

The Fundamentals of GMP Cleanroom Classifications

The clean air grades and classifications established by GMP dictate the appropriate environment for producing sterile drugs and biological products. Sterile product manufacturing is categorized into four areas – Grade A, B, C, and D – in compliance with GMP guidelines. Understanding the requirements and grades of GMP can be challenging, especially when dealing with [Read More…]

Pharmaceutical Manufacturing, Revisiting the Unexpected with Growth

pharmaceutical-cleaning-supplies

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…]

Cleanroom vs. Controlled Environment

Cleanroom vs. Controlled Environment

What is the difference between a cleanroom and a controlled environment? Do you know what a Cleanroom (clean room) is? A cleanroom is  a controlled environment that restricts the number of pollutants or contamination to a specific number of particles per cubic foot or cubic meter. Cleanrooms are regularly tested to ensure they meet the [Read More…]