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)
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?
USP 797 Garbing and Donning Requirements: Current Standards and Best Practices
View USP 797 gowning standards and core requirements. For sterile processing, additional precaution is needed to assure that no sterile surfaces contact non-sterile surfaces during gowning, processing, or cleaning. Sterile garments and gloves are recommended during aseptic workflows.
Aseptic Processing Guidelines – Most Common FDA Inspection Notes
The majority of contamination within aseptic processing cleanrooms involves personnel. Proper application of gowns, hygiene, and a work flow can often eliminate the majority of mix ups and contamination.
Gowning Room Design – Guidelines, Anterooms, and ISO Classification
A gowning room has many variables. There is no mathematical formula when determining the features, surfaces, and HVAC requirements best suited for your application. Space requirements, volume of operators, aseptic workflows, material choice, and even aesthetics all factor into design considerations. Most facilities benefit from contacting a controlled environment specialist who can identify critical product sensitivities, storage requirements, and operational standards.
Sterile Plant Tissue Culture Requirements: Environments, Chemicals, Garments
What do I need to tissue culture plants? What are the advantages of tissue culture? This article provides basic environment design, supplies, and protective requirements for non-hazardous sterile processes during the cell culturing and micro-propagation of clones. Learn about the tools and equipment required for aseptic workflow during tissue culture processes.
Particulate Matter – What is it and what are the health effects?
Historically, air quality has shown a complex relation to respiratory issues, birth defects, chronic illness, cancer, and even loss of cognitive function. Research suggests air pollution affects everything from neurodevelopment in-utero to cognitive decline in older people.
Proper Material for ESD Cleanroom Gloves
ESD cleanroom glove materials have reduced NVR (non-volatile residues) levels for better electrical conductivity. Meanwhile, dedicated ESD fabrics are often not viable for cleanroom use, as they tend to shed particulates at a much higher rate than latex, nitrile, or vinyl gloves.
Immunology and Microbiology Cleanrooms
Large clinical-scale cleanroom operations for T cell therapies often use a class ISO 7 (Class 10,000) cleanroom room environment with an ISO 5 (Class 100) biological safety hood.
Medical Device Cleanroom Classification
What Kind of Cleanroom Do I Need for a Class II Medical Device? What About Class III? This post classifies medical device cleanrooms for manufacturing and packaging.
Advantages of Peracetic Acid Sporicides
What are the advantages of peracetic acid sterilants for cleanroom disinfection? Where is it used? How does it compare to gas sterilization methods?
Cleanroom Fan Filter Replacement
When Should I Replace a Cleanroom Fan Filter? Pre-Filter Replacement Pre-filter media should be replaced every six months and inspected regularly. Pre-filters in gowning rooms
Guide to USP <1072> Disinfectants & Sporicides
USP <1072> outlines decontamination practices for critical environments.In this post, we’ll outline the types of chemical disinfectants and sterilants used in cleanrooms and laboratories. This includes isopropyl alcohol, bleach, formaldehyde, hydrogen peroxide, and peracetic acid.
ISO 7 Cleanroom Panel Cleaning & Maintenance
Warm water and a mild dish soap is the best softwall curtain cleaning solution. What about acrylic, melamine, and aluminum? Generally, any biodegradable solution is acceptable. A 50/50 solution of Isopropyl Alcohol & DI water is also effective. Wash curtains front side and back, rinse with clean water, then wipe dry with a clean lint-free soft cloth.
Cleanroom Fan Filter Units vs Air Handling Units
A cleanroom air handling unit (AHU) is a cornerstone of temperature, humidity, and pressurization within controlled environments. Today, modular fan filter units allow more adaptable configuration with simplified maintenance procedure. Both systems serve conditioned and filtered air throughout a cleanroom facility.
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.