USP <800> Compounding Cleanrooms

USP 800 is a cleanroom compounding standard that was issued in March of 2014 by the United States Pharmacopeial Convention (USP). It’s primary focus is expanding the safety of healthcare workers, patients, and the environment for processing hazardous drugs. It’s scope reflects a number of stages in the delivery of sterile and non-sterile compounds, including:

Why is Modular Cleanroom Design A Huge Development?

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Pre-engineered fabrication consolidates scheduling with minimal disruption and fewer variables. Difficult or expensive upgrades avoid overbearing noise, construction artifacts, and minimize if not eliminate the burden on facility staff for project management. Project leads enjoy fewer phone calls, emails, and headaches. CleanPro designs an environment unique to your facility, and guarantees testing and validation that its meets your state, federal, and organizational goals for you application.

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.

Cannabis Cleanroom Design and Construction Components

medical cannabis grow room

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 

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

This guide provides a framework for employees entering a cleanroom.

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

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.

Cleanroom Cleaning, Gowning, and Maintenance — Procedure, Contamination Control, and ISO Protocol

cleanroom gowning and procedure

Proper cleanroom cleaning procedure and maintenance protocol is an immediate, low-cost measure to enhance overall cleanliness, consistency, and contamination control within manufacturing and aseptic cleanrooms. This guide provides a framework for cleanroom management, protocol standards, specifications, and processes for general manufacturing and bio-medical applications.

Everything You Need to Know About Building A Cleanroom: ISO Class Prefab Hardwall Cleanroom Design

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Advantages for Modular Hardwall Design and Construction of ISO 14644-4 Cleanrooms.

The Hidden Costs of Acrylic: Enclosures, Cabinets, and Desiccators

Why Is Static Dissipative PVC a Better Option than Acrylic?

Are Automatic Shoe Cover and Medical Bootie Dispensers and Removers Worth the Cost?

cleanroom gowning and procedure

High-traffic cleanrooms use tightly controlled procedures with repeatable processes to maximize the passage of people in and out of sanitary environments. Cleanroom facilities of all sizes find advantages in using automatic shoe cover removers and dispensers to improve adherence to procedure, maximize throughput, cleanliness, and safety. The result is cost savings of up to $250+ … Read moreAre Automatic Shoe Cover and Medical Bootie Dispensers and Removers Worth the Cost?

What You Must Know about Designing and Constructing a Cleanroom

There are numerous considerations when evaluating cleanroom construction and design. The goal of this post is to touch on the basics. You may very well need to employ the services of a cleanroom consultant to help you. Here are a few things to keep in mind for design and construction of cleanrooms and controlled environments. … Read moreWhat You Must Know about Designing and Constructing a Cleanroom

The Seven Deadly Sins of Cleanroom Wiping (and How to Avoid Them!)

Cleanroom wipe on stainless steel.

1. Ignoring the Need to Wipe on a Regular Basis To assure quality is maintained in all cleanroom and restricted areas, housekeeping maintenance must be performed daily. Improper cleaning leads to contamination and ultimately loss in end user product quality. Contamination can be broadly categorized into two categories, films and particulates, both of which can cause … Read moreThe Seven Deadly Sins of Cleanroom Wiping (and How to Avoid Them!)

Air Showers: Increasing Productivity & Reducing Costs of Cleanroom Operations

Article reprinted from Clean Air Products, manufacturers of air showers, cleanrooms, and cleanroom accessories. A cleanroom provides a controlled environment in which companies can produce contaminate-free products. Air showers are a vital component of maintaining that clean environment. They protect the cleanroom by using high-velocity jets of air to remove loose particles of contamination from … Read moreAir Showers: Increasing Productivity & Reducing Costs of Cleanroom Operations