Air Ionization for Particulate & Contamination Control PDF from Simco-Ion
Our friends at Simco-Ion sent us this brilliant guide to ESD cleanrooms design, principles, and other considerations. Download the PDF you’ll find case studies and technical information about how static charges influence particle retention and impact manufacturing outcomes in controlled environments. Below we’ve highlighted important ideas in relation to medical device cleanrooms and provide additional resources.
Cleanrooms for Satellite & Spacecraft Construction
For communication satellites that remain within earth’s orbit, an ISO Class 6-8 cleanroom allows sufficient particle and contaminant control. Cleanroom engineers design each space so that particles from production surfaces are whisked away from critical components. A combination of softwall production areas and hardwall cleanroom facilities provide isolation of critical tasks.
How Often Does a Particle Counter Require Recalibration?
For ISO 14644 compliance, all particle counting equipment requires a calibration certificate.
How CleanPro® Makes Common Items into Critically Compliant Cleanroom Equipment
Find hand dryers, laboratory receptacles and cleanroom mirrors. New from CleanPro with quick ship options.
ISO 13485:2016 Medical Devices
ISO 13485 is designed for use throughout the life cycle of a medical device. It supports each stage of medical device development and operation from initial concept to production and disposal. The standard helps internal and external parties certify and validate processes which maintain the stability of quality management systems (QMS).
New: Perfex Cleanroom Mop & Disinfection Systems
Perfex cleanroom mop and disinfection systems are designed for easy use and maintenance for critical operations. It’s the cleaning performance you’d expect beyond old-style buckets, wringers, string and sponge mops.
What’s the Difference Between Sterile and Aseptic Technique?
Are the terms sterile and aseptic used interchangeably? Is a cleanroom sterile? What is aseptic processing?
New: Particles Plus Cleanroom Particle Counters and Air Quality Monitors
Cleanroom particle counters and anemometers offer portability, accuracy, and easy use. The self-contained devices allow local and off-site testing of air quality, air speed, HVAC efficacy.
New: Vileda Professional Cleanroom Products
Vileda Professional Cleanroom Mops support most critical applications. Find stainless steel mop sets and handles, or ask about quantity discounts on Vileda mop refills, pads, and accessories.
USP <800> Compounding Cleanrooms
Updated: USP 800 is a cleanroom standard issued in March of 2014 by the United States Pharmacopeial Convention (USP). The deadline December 2019 for compliance may change.
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.
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. Updated: 4/18/2019
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.
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
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?
New: Elma Ultrasonic Cleaners
Elma Ultrasonic Cleaners – Where to Buy Online? Elma introduced its ultrasonic cleaners to the world over a half century ago. Today, its systems stand
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,
Cleanroom Classification Comparison Specifications Defined
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. The thousands of people who all wear “bunny suits” to protect products from from human particles such as skin flakes or hairs. A bunny suit is made of unique, non-linting, anti-static fabric and is worn over street clothes.