Sterile compounding pharmacy cleanroom apparel is widely used in sterile compounding pharmacy facilities. USP 797 compliance and the USP 800 compliance requirements give direction on apparel for cleanroom workers a compounding pharmacy. With the primary focus being maximum coverage of clothing, hair, skin, and nails, Cleanroom Connection recommends that pharmacies use a one-piece cleanroom coverall with attached hood and boots, often referred to as a bunny suit. This style of pharmacy cleanroom apparel simplifies the gowning procedure while at the same time eliminates the possibility of skin exposure at the neck and ankles. Often times, pharmacists and workers wear a separate coverall, hood, and shoe cover which potentially can expose skin when they stretch or lean if the apparel fit is not correct. Because the goal is to prevent particles from entering the pharmacy clean room, the disposable apparel should be non-shedding.
What Classifies As Non-Shedding Pharmacy Cleanroom Apparel?
While USP 797 calls for non-shedding or non-linting apparel to be worn while working in clean areas, the term “non-shedding” is very loosely used by cleanroom apparel manufacturers. Among the most popular materials marketed as lint-free or non-shedding are Tyvek, SMS, microporous-coated, and polypropylene. All of these materials are marketed as non-shedding pharmacy cleanroom apparel, however they are not all equally non-shedding. Cleanroom Connection has evaluated all of these materials and determined the below list to be acceptable cleanroom apparel materials for USP 797 compliance. The below compounding pharmacy apparel is listed in order of cleanest to least-clean:
- Tyvek pharmacy cleanroom apparel
- Microporous-coated (MP) pharmacy apparel
- SMS tri-laminate cleanroom apparel
- Polypropylene non-shedding apparel
Real-World Feedback From Top Compounding Pharmacies
Cleanroom Connection supplies over 500 independent sterile compounding pharmacy cleanrooms as well as hospital-based compounding pharmacies. Based on customer feedback, FDA inspections, and other regulatory testing including particle testing, polypropylene is not recommended. Although polypropylene is classified as non-shedding, it tears very easily, releasing particles. Because it is also the cheapest of the non-shedding pharmacy cleanroom materials, it is often chosen due to the promise of cost savings. This cost-cutting decision often backfires due to cleanliness issues that affect product quality and worker safety. Cleanroom Connection often receives complaints from pharmacists and workers about the blue polypropylene shoe covers, which are made from the same weak material.
Recommended Pharmacy Cleanroom Apparel Materials
Proper selection of non-sterile or sterile compounding pharmacy material is based on the level of cleanliness required for the controlled environment.
|Cleanroom Facility||Recommended Compounding Pharmacy Cleanroom Apparel Material|
|ISO7, Class 10,000||SMS|
|ISO6, Class 1000||Tyvek or MP|
|ISO5, Class 100||Dupont IsoClean clean-processed Tyvek or MicroGuard CE clean-processed|
All cleanroom clothing that is allowed to be worn in an ISO5 Class 100 facility will be clearly labeled on the packaging or on the data sheets specifying Class 100 ISO5 compatible.
Get Proper Pharmacy Cleanroom Apparel Advice
Cleanroom Connection works alongside PCAB, IACP, USP and top pharmacy consulting firms in being educated about what cleanroom apparel is expected to be worn in sterile compounding pharmacies. Often times the incorrect cleanroom suits are offered to pharmacies by suppliers that have little knowledge about working in a clean room or pharmacy.
Contact Cleanroom Connection to discuss your sterile compounding pharmacy cleanroom apparel needs and get expert guidance on USP 797, USP 800, and other applicable cleanroom protocols. Free samples and professional guidance from a veteran compounding pharmacist is available at no charge. Get guaranteed lowest pricing on all non-sterile and sterile compounding pharmacy cleanroom supplies.