USP Postpones USP 797 and USP 795 Deadline Until Further Notice (Nov 2019)
As of November 22nd, 2019, the USP will delay implementing previously suggested changes to USP 795 and 797 chapters until further notice.
Medical Device Cleanroom Construction Part 6: Pressure Differentials, Humidity and Temperature Calibration
The central controller integrates the data from both the thermostats, fan filter processors, and room-side environmental sensors. Fan filter speed is then adjust by each group to achieve the specified room pressure while at ideal temperature and humidity.
Medical Device Cleanroom Construction Part 5: HVAC Balancing & Calibration
Before cleanroom validation, a cleanroom requires mechanical calibration. HVAC calibration first ensures that the room meets the performance parameters which would deliver the expected results during final ISO validation, such as differential pressure, air change rates, and uniform airflow distribution.
Medical Device Cleanroom Construction Part 4 – VCT Flooring Design
There are a few final preparations required before the final cleanroom flooring installation. Here’s what to expect and consider for cleanroom tile installations and flooring installation.
Cleanroom Fan Filter Testing and Maintenance – HEPA Filter Replacement and Troubleshooting
How do I know when to replace my cleanroom HEPA air filters? How do I test a cleanroom HEPA filter? What are the best practices for cleanroom HEPA filter replacement?
What Are the Differences Between Corona and Alpha Ionization?
This post covers the different types of static control ionization equipment and technologies. Which is best for your application?
Medical Device Cleanroom Construction Part 3: Fan Filter Units – Ceiling Grids
In this post, we overview technical considerations for clean room fan filter unit selection, installation, and features. You’ll learn how PAC approaches design and configuration
Medical Device Cleanroom Construction Part 2: Doors, Electrical, and Layout
In medical device cleanrooms, a common configuration is an ISO 8 gowning room and ISO 7 primary production area. A cascading air flow design and
Medical Device Cleanroom Construction Part 1: Walls and Installation
How is a medical device cleanroom built? Here’s a component-by-component guide to ISO Class 7 cleanroom construction.
E-Liquid Clean Rooms – E-Liquid Labs and Cleanroom Classifications
What are the advantages of cleanrooms for e-liquids? What are the American E-liquid standards for the FDA, and ISO cleanrooms? Does the FDA require a cleanroom for e-liquids and e vape products?
USP 800 Cleanroom Construction Hazardous Compounding: Options and Alternatives
There are a few options available to cleanroom facilities who require new upgrades for USP 800 compliance. The best option will depend on the variables
Polycellulose & Polyester Cleanroom Wipe Supplies
Here’s the guide to buying cleanroom wipes that stay on-budget. Differing package sizes, bulk counts, edge types, material options, cloth size, weights, ISO class, substrates, ionic levels…comparing cleanroom wipes is mind numbing. 50% of leading cleanroom wipe advertisers don’t even offer prices online!
USP 800 Cleanroom Design – Negative Pressure Changes and Requirements
What equipment and engineering controls do USP 800 cleanrooms require? What types of storage and monitoring systems will I need?
Cleanroom Ionizer Selection Guide
What is the advantage of ionizers for static control and particle cling? How do I select the right ionizer? View the selection guide.
How do I Calculate ISO 5 Cleanroom Air Change Rates (Class 100)
What is the proper way to calculate ISO 5 cleanroom air change rates? View ISO air velocity requirements and cleanroom benchmarks. (Class 100)
USP Posts Revised PDFs for USP 795, 797, 800, 825 – Updated November 2019
Updated November 2019: Where can I find updated USP 800, 797, and other compounding documentation? Are there any recent changes to USP documents? When is the official deadline for USP 800 compliance?
Evolving Research and Studies on Particulate Matter, Health & Pollution
The health impacts of polluted air and particulates vary by the form and size of particulate. Learn about different types of particulates and find updated research.
The Truth about Cleanroom Air Change Rates, Charts & Methods of Calculation
Why Can’t Anyone Agree on Benchmarks for Cleanroom Air Change Rates? There are a number of best practice guides and benchmarks for cleanroom air change
Guide to Remote Particle Counters and Air Quality Monitoring Systems
Learn about the newest WIFI & IOT enabled air quality monitor features. Remotely monitor indoor & outdoor air quality including PM2.5 – PM10 particles, dust, C02, & VOCs.
USP 800 Gowning – Chemotherapy Gloves, Gowns
What are the essential requirements for USP 800 gowning? What kind of gloves and gowns do USP 800 hazardous drugs require?