Quest Safety Products is expanding its product line to include more products for controlled environments, sterile environments, and cleanrooms. Quest is proud to have 11 of the top pharmaceutical companies as customers and this addition helps us provide them with a more complete product line.
Quest’s Territory Managers’ have been through hours of training on PPE. We, along with our supplier partners, are ready to work with your Industrial Hygienists to find the right garments to fit your ISO classification, possible hazards, and exposure levels. We have also created a catalog devoted to PPE for controlled environments. Let’s discuss your garmenting needs or issues and together we’ll find the right solution. Our initial focus has been on product lines from DuPont, Ansell, and Lakeland. We can also source from other manufacturers as needed by our customers.
The First Step is Understanding Your Controlled Environments
The term Controlled Environment, sometimes also referred to as critical environments, is an overarching term for areas that are extremely regulated in terms of how the room is designed and equipped, what type of work is done in the room, and how employees work within them.
All Controlled Environments control temperature, pressure, and are separated from other areas within the facility. Some controlled environments also control humidity.
There are two types of controlled environments that require special personal protective equipment: cleanrooms and sterile environments.
Cleanrooms are highly controlled indoor environments. Similar to controlled environments, the temperature, humidity, and pressure are controlled to required levels. The air entering the clean environment is filtered by air handling units usually equipped with HEPA filters. What differentiates cleanrooms is the regulation of particulates (dust, airborne organisms, or vaporized particles) in the air per cubic meter. The US General Service Administration’s ISO 14644-1 system classifies clean rooms into nine classes depending on the industry requirements.
Workers in these rooms are required to wear PPE that are clean-manufactured at a minimum. This is why it is key to work with PPE manufacturers and distributors who understand cleanroom requirements. Our partner, Lakeland highlights the importance of clean-manufactured garments well:
A clean-manufactured garment is sewn and constructed in a controlled, clean-manufacturing environment. A clean-manufacturing facility ensures that:
- All of the assembly operators are trained in good cleanroom hygiene and clean manufacturing principles.
- Each employee is gowned in the class appropriate cleanroom apparel.
- Work surfaces are disinfected and wiped clean at predetermined intervals throughout production.
Most importantly, a clean-manufacturing facility ensures that operators are not adding any particulates onto the garments during the construction and manufacturing process.
Cleanrooms are used for manufacturing products such as electronics, pharmaceutical, and medical equipment.
Sterile Environments require all the controls of controlled environments and go one step further. Sterile environments must be completely free of bacteria and microorganism. Employers must use PPE that has undergone a sterilization process. This is another case where knowing your PPE manufacturer and distributor can help determine your success in meeting specific regulations.
Such environments are usually required for very specific tasks such as pharmaceutical manufacturing.
For additional information on Clean vs Sterile Garments, check out Lakeland’s article Clean vs Sterile Manufacturing: Why it Matters for Your Cleanroom Apparel.
Why Is PPE So Critical For These Environments?
PPE is key in controlled environments to protect the products, workers, and facilities.
Per OSHA, protective head, foot, and body coverings are required in a cleanroom to reduce particulate contamination. In cleanroom and sterile environments, about 80 percent of the impurities come from people. This includes skin flaking, microbes, hair, textile fibers, and dust which can cause serious problems.
In addition, employees must wear the required PPE to protect them from the materials and processes used. Protective clothing is the most important PPE for controlled environments. In addition to protective garments there is eye protection, face masks and shields, as well the appropriate gloves made specifically for controlled environments. In some cases respiratory protection may be required – remember that respirator use requires special medical qualification, fit testing, and training.
OSHA standard 29 CFR 1910, more commonly known as the General Industry Standard, outlines a variety of cleanroom requirements and dictates that employers must provide PPE for the eyes, face, head, and extremities. Whether reusable or disposable, these must be used and maintained in sanitary and reliable conditions.
WE’RE PREPARED TO HELP
We understand that cleanroom garment classification alone is complicated:
- Clean / Sterile
- Clean / Non-Sterile
- Non-Clean / Sterile
- Non-Clean / Non-Sterile
Additionally, there are numerous garment styles, autoclavable options, and packaging choices. All of these PPE garment features are determined by the type of controlled environment your team works in. We’re here to help you find what products are available to fit your needs.
Check out our Controlled Environment Catalog. We’ve designed the catalog to focus on the type of garment and the coverage needed to help you find products easily. The contents page is shown here.
You can access the Quest Controlled Environment Catalog here.