USP 797 Guidelines: Sterile Compounding Cleanroom Design, Components, and Procedure

USP Chapter 797 cleanroom design requires that facilities pressurize non-hazardous compounding and storage areas. ISO 5, 7 and 8 environments support primary engineering controls, buffer rooms, and ante-rooms.

Upgrading a USP 797 Cleanroom to USP 800?

USP 800 cleanroom upgrades - ISO 5 with ISO 7 Buffer room

New USP guidelines may present challenges for compounding facilities. Some facilities need infrastructural and mechanical modifications for compliance. System evaluation includes duct systems, HEPA fan filters, differential pressure standards, air monitoring, and external air exhaust equipment.

How Does USP 800 Change Storage and Unpacking of Hazardous Drugs?

Facilities unpacking hazardous drugs within a negative pressure room do not require procedural changes to meet USP unpacking area requirements. Facilities unpacking HDs within positive pressure ante rooms or facility spaces will require reconsideration.

Cleanroom and Sterile Compounding Glossary and Definitions

Cleanroom Biosafety Cabinet

The definitive cleanroom and sterile compounding glossary. Learn terminology and definitions for USP 797 and USP 800 compounding.

Cleanroom Construction FAQ

Definitive Cleanroom Construction FAQ: How much does a cleanroom cost? How does the level of ISO classification impact build and operating costs? How much supporting space will I need for a cleanroom addition or ISO class upgrade? What’s the advantage of a turnkey cleanroom system?

Cannabis Cleanroom Design and Construction Components

Cannabis Cleanroom Construction This post regards the specific construction components of building a cleanroom for medical cannabis cultivation. Previously, we’ve written about the dangers of contaminated cannabis, and how it affects the overall quality and safety of cannabis products. Cleanroom construction factors a number of variables, in this post we’ll outline the structural requirements and … Read moreCannabis Cleanroom Design and Construction Components

Fingerprints of a Killer: Why Medicinal Cannabis Needs a Cleanroom Engineered Solution

Growing medical cannabis in cleanroom inspection

The benefit of modular cannabis cleanrooms over traditional fixed wall grow rooms is that the configurable partitions of modular cleanroom designs lower the cost of installation or re-configuration for changing regulations. Divider rooms total environmental control, larger yields, and improve regulatory compliance at various stages of the growing cycle.

Cleanroom HEPA Vacuum Use and Applications 

cleanroom vacuume

Cleanroom HEPA Vacuum Components and Applications Simply put, every square inch of a cleanroom should be absolutely pristine. Ceiling panels, lighting units, HEPA filtration units, sprinkler heads, walls, glass surfaces, process equipment, piping systems, floors, and manufacturing equipment should all be decontaminated regularly. Even the ambient air must be monitored and maintained at proper levels. … Read moreCleanroom HEPA Vacuum Use and Applications 

Cleanroom Classification Comparison Specifications Defined

Cleanroom Bunny Suits Used by Nasa

A comparison of cleanroom classifications and specifications.

Entering a Cleanroom: Preparation and Procedure – The Garments Employees Must Wear

This guide provides a framework for employees entering a cleanroom.

Turnkey Cleanroom Install

CleanPro’s turn-key cleanroom solution provided a one-stop, one-contact result for the initial delivery and on-site installation of walls, ceiling grids, electrical systems, flooring, filters, HVAC, and more.

Softwall Cleanroom Curtains Project

Softwall cleanroom curtains, sometimes referred simply as “plastic strips” yield ISO Class 10,000 level particle control with minimal construction. This customer required a custom softwall installation that integrated into their existing building structure CleanPro to deliver a softwall cleanroom

Clean-Forward Lab Furniture Project

Industrial workbenches and workstations provide integrated design features such as power bars, application specific surface materials, and custom drawer and cabinet configurations for safe, organized storage. This laboratory enlisted for a complete laboratory outfit, with ergonomic seating and Lista drawer cabinet workstations.

Chemotherapy and CSP Cleanroom Installation

This modular, sterile compounding cleanroom is designed for ISO 797 and ISO 800 compliance, particularly for compounding chemotherapy drugs. Safe handling of sterile compounds requires special considerations: heat-welded floors, anterooms and buffer areas.

Class 10,000 Cleanroom & Gowning Area

This cleanroom and adjacent gowning area helped this customer prevent outer contamination from entering classified spaces.

CleanPro® Stand Alone Hardwall Cleanroom

CleanPro’s modular hardwall cleanroom solutions adapt alongside changing floor and production layouts.

Softwall Cleanroom Enclosure

This customer needed to enclose a piece of machinery, and CleanPro® was able to provide a solution.

Cleanroom Installation Examples by CleanPro®

Here are some best-in-class cleanroom projects, in which the PAC cleanroom division, CleanPro, provided expertise and turnkey execution for design and installation of cleanroom enclosures, furniture, and components.

Cleanroom Components — Air Filtration, Design, and Other Variables

cleanroom installation photo install

What are the key determinants of cleanroom components? Learn about different types of cleanroom filtration, wall construction, lights, temperature, humidity and more.

How to Choose the Right Cleanroom Particle Counter

cleanroom particle counter in use

Cleanroom particle counters differ widely based upon particle threshold, cost, and features. How to do you determine if you need a particle counter or what model of particle counter to purchase? In this article we will go over the basics of particle counters and give you the facts to help you determine which one is best for your cleanroom application.