USP 797 / 800 Compliant Supplies – Products for Aseptic Areas and Where Sterile Compounding is Performed
We offer a variety of product lines that help sterile cleanrooms and 503A and 503B pharmacies maintain compliance with USP Chapters 797 & 800. These products include cleanroom wipes, sterile wipes, non-shedding mop systems, disinfectants, cleanroom sticky mats and more. Please contact us so we can find the best solution for your unique requirements.
There are a variety of product requirements set forth in USP 797 and USP 800 that help maintain quality standards for sterile compounding. In addition to USP 797 and 800, there are industry-specific (as well as organization-specific) guidelines that exist. To maintain full compliance, make sure to follow the guidelines specific to your situation.
Helping 503A and 503B Compounding Pharmacies Meet USP Compliance
The Food and Drug Administration (FDA) has implemented regulations for compounding pharmacies, separating them into 503A and 503B facilities. Pharmacies that fall within these designations are required to comply with a variety of USP guidelines. We’ll help you select the proper products to help your pharmacy maintain compliance.
- Floors, walls, ceilings, shelving, hard surfaces, contaminated gloves, and supplies removed from shipping cartons are to be wiped with 70% Sterile Isopropyl Alcohol.
Our sterile wipes offer the following:
- Validated to SAL (Sterility Assurance Level) of 10–6 in accordance with standards and recommended practices of the ANSI/AAMI/ISO 11137:2013 guidelines
- Each package is identified with a lot number
- Each case of material includes a Certificate of Irradiation
- IPA filtered to 0.22μ
- Only use gloves labeled as ASTM-tested chemotherapy gloves.
- Use powder-free gloves
- Avoid gloves with defects, pin-holes or weak spots.
- Wear two pairs of ASTM-tested gloves when compounding, administering, managing a spill, and disposing of Hazardous Drugs. For sterile preparations, only the outer glove needs to be sterile.
- Wear the inner glove under the gown cuff and the outer glove over the cuff. Place gloves with long cuffs over the cuff of the gown to protect the wrist and forearm.
- Wear disposable gowns that have been tested to resist permeability by HDs and will protect the individual from contact of any HD’s.
- Wear garments that cover the head, sleeves, and shoes.
- Eye and face protection shall be worn when handling HD’s outside an engineering control.