Cleanroom

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:

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cleanroom installation photo install

Why is Modular Cleanroom Design A Huge Development?

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.

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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.

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

Upgrading a USP 797 Cleanroom to USP 800?

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.

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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.

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Cleanroom Biosafety Cabinet

Cleanroom and Sterile Compounding Glossary and Definitions

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

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medical cannabis grow room

Cannabis Cleanroom Design and Construction Components

This post regards the specific construction components of ultra-clean cannabis grow rooms. Previously, we’ve written about the correlations of contaminated cannabis, and how it affects

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Growing medical cannabis in cleanroom inspection

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

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.

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cleanroom vacuume

Cleanroom HEPA Vacuum Use and Applications 

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,

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

This guide provides a framework for employees entering a cleanroom.

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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

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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.

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cleanroom installation photo install

Cleanroom Components — Air Filtration, Design, and Other Variables

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

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Modular-Hardwall-Cleanroom-Image

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

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

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cleanroom gowning and procedure

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

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

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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

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Cleanroom wipe on stainless steel.

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

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

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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

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Simco-Ion TargetBlower 6202e

The TargetBlower is an in-tool ionizing blower designed to control static charge in near critical environments. With ±5V or better balance, it meets the requirements for

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Palbam Class N2 Desiccator Cabinets

Desiccators: Unique Stainless Steel Solutions from Palbam Class Palbam Class developed its first desiccator cabinets for the Semiconductor Industry. Due to the demands of this

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