Keeping Pharmaceutical and Cleanroom Environments SafeComplete cleanliness of laboratory facilities and pharmaceutical plants is vital. There is the immediate safety of workers to remain safe from chemical hazards at all times, as well as the health and well-being of millions of consumers/patients in the long-term. CFR and ISO have developed a variety of regulations to help with these safety concerns.
Keeping Pharmaceutical and Cleanroom Environments Safe
Complete cleanliness of laboratory facilities and pharmaceutical plants is vital. There is the immediate safety of workers to remain safe from chemical hazards at all times, as well as the health and well-being of millions of consumers/patients in the long-term. To provide patients the highest quality prescriptions available – developed in the cleanest, safest laboratories and plants possible – CFR and ISO have developed a variety of regulations.
These regulations range from facility layout and furnishing plans (to ensure chemical resistance) and equipment contamination control, to air cleanliness and pharmaceutical drugs’ quality and purity characteristics. As a result of these regulations, laboratory facilities and pharmaceutical plants can achieve their greatest potential as they continue to develop life-altering and life-saving drugs.
29 CFR 1910.1450: Hazardous Chemicals in Labs – App A (U.S.)
These non-mandatory recommendations include plans for laboratory facility layouts and furnishings, which suggest that work surfaces and walls should be chemically resistant, smooth and easy to clean and maintain. In turn, the work surfaces and walls will help improve employee safety considerably.
By providing high speed doors (part of walls) that are not only smooth, but can also be washed down, organizations can improve their workers’ safety as they’ll be better protected from potential chemical hazards.
21 CFR Part 820 Part G: Production and Process Control (U.S.)
Subpart E of this regulation requires manufacturers to control the contamination of their equipment by substances that could potentially have an adverse effect on overall product quality. By controlling this contamination, manufacturers can develop and deliver a product their customers can rely on.
Aside from controlling contamination, manufacturers must also focus on cross contamination, yet another significant issue that’s influencing product quality. To help prevent this issue, high speed doors that are made from tough PVC vinyl and Urethane should be considered.
ISO 14644-1: Levels of Clean Rooms (INTERNATIONAL)
This international code was developed to provide a class system, testing methods and equipment requirements for various classes of air cleanliness in pharma and electronics operations. Air cleanliness is classified according to the concentration of airborne particles in cleanrooms and clean zones; particles outside of the regulation’s specified lower threshold particle-size range, 0,1 µm to 5 µm, aren’t classified.
It is critical for high speed doors often used in pharma and electronics plants’ laboratories to meet the specific codes that are outlined in in ISO 14644-1.
cGMP CFR 21 Part 210 (U.S.)
The regulations established in Part 210 feature the minimum and current good manufacturing practice (cGMP) that methods should be used in – along with the facilities or controls that should be used for – the manufacturing, processing, packing or holding of a drug. As a result, the drug will meet the requirements of the act, in terms of safety, while also having identity and strength, and meeting the quality and purity characteristics it either purports or is represented to possess.
To meet or exceed these requirements, it is important to know cGMPs and then find the proper equipment, including high speed doors and door controls, that are required for such regulations.
Keep Clean, Keep Safe
The lives of workers and health-compromised patients depend on pharmaceutical facilities to follow all cleanroom standards. It’s essential that safety and operations managers continue to uphold those standards and remain diligent in their pursuit for cleanliness by using all methods and equipment available.
This blog was developed from the Essential Guide: Safety Regulations. For additional information on these topics and a full list of sources, click here.
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