Custom Explosion-Proof BioSafe® All-Steel Modular Cleanroom

The guide is applicable to operations for manufacturing medicines in their finished dosage forms, including large-scale processes in hospitals.

This article outlines 8 key steps for keeping cleanrooms in healthcare/pharmaceutical facilities in a state of microbiological control.

This guide explains specific steps companies should follow to complete a cleanroom project, be it a new build or upgrade.

This article provides a methodology to evaluate the environmental impact of an air handling unit shutdown in a GMP manufacturing environment.

This Slideshow outlines 5 commissioning steps: design phase, installation verification, operational verification, functional verification, and post occupancy.

Recommended procedures for donning and doffing PPE for cleanrooms and containment labs.

This document includes recommended garbs for each cleanroom classification, plus a basic gowning procedure.

These guidelines focus on recommendations for HVAC systems used in facilities manufacturing non-sterile pharmaceuticals (capsules, powders, liquids, creams).

This document outlines aseptic manufacturing facilities, equipment qualification, and cleaning validation.

This guidance is intended to help manufacturers meet the requirements in the FDA's current good manufacturing practice (CGMP) regulations.

This document answers the 5 W's (who, what, when, where, why), plus other questions regarding cleaning products and procedures in compliance with USP 797.

This document has been developed in accordance with the current applicable USP 797 guideline. It is intended for use as a guideline only.

Worst case event response should be detailed in a Facility Cleaning Standard Operating Procedures. This document outlines recommended guidelines and protocols.