Cleanroom Operating Procedures
By Jan Eudy
We are building an ISO Class 7 (formerly Class 10,000) modular cleanroom on our university campus. Our students will wear bouffants, shoecovers, and frocks. Is there a gowning protocol for frocks?We also need procedures for cleaning the modular cleanroom and working in the cleanroom.
Testing ESD Garments
By Jan Eudy
Is it appropriate to test an ESD garment on an operator?
Arc Thermal and Flame Resistant Cleanroom Garments
By Jan Eudy
My company’s Health & Safety Committee requires all cleanroom operators that perform maintenance on equipment in the cleanroom to wear protective garments that are arc thermal and flame resistant.
Environmental Monitoring For Cleanrooms and Other Controlled Operations
By Jan Eudy
I must establish and implement an environmental monitoring program for our new food packaging facility. What testing is needed?
Protection or Hype? Making Sense of Anti-Microbial Fabric Coatings
By Robert Nightingale
In a climate of pandemics, acquired immune diseases, and common viruses, the demand for products claiming to have anti-microbial properties has risen substantially.
Gowning Protocol for Cleanroom ARC Thermal and Flame Resistant Garments
By Jan Eudy
My company’s Health & Safety Committee requires all Cleanroom operators to wear protective garments that comply with NFPA 70E.
ESD Garments for Cleanrooms and Controlled Environments
By Jan Eudy
We are looking to improve our ESD control with static control garments. What are our options?
The Human Element
By Damon Larkin
Minimizing contamination risks in sterile gowning
Testing Consumable Products For Cleanrooms
By Jan Eudy
It is recommended that when comparing cleanroom consumable products manufactured by several vendors that all products be tested at the same lab, with the same test method, and by the same technician. What test methods are recommended for cleanroom consumable products?
Establishing and Implementing an Environmental Monitoring Program for Non-Sterile Operations
By Jan Eudy
I must establish and implement an environmental monitoring program for our new ISO Class 6 cleanroom that packages medical devices for terminal sterilization by gamma radiation. What do I need to know in order to do this correctly?
Converting From an Uncontrolled Space to a Cleanroom
By Jan Eudy
Our company is shifting focus from the manufacturing of medical device components in a controlled environment to manufacturing in a certified ISO Class 8 environment.
When Should Cleanroom Garments be Replaced
By Jan Eudy
I recommend an objective testing of the cleanroom garment and fabric as well as establishing the efficacy of particle entrapment, the lack of particle shedding, and ESD efficacy as the criteria for replacement.
Point of View: Safety Shoes
By Patrick Smyth
The steel toecap safety overshoe has been around for a long time. Its origins lie in the marriage between the venerable rubber galosh and a steel toecap similar to those used in many of today’s safety boots. That has changed now because of a number of developments.
Basic Cleanroom Protocol
By Jan Eudy
Can you please recommend a basic protocol program for cleanrooms?
Understanding Cleanroom Apparel Sterilization, Part 2
By Jan Eudy
How are cleanroom garments validated as sterile for use in an aseptic cleanroom using the VDmax method?
Understanding Cleanroom Apparel Sterilization, Part 1
By Jan Eudy
How are cleanroom garments validated as sterile for use in an aseptic cleanroom?
Fabric and Garment Testing for Cleanrooms, Flame Resistance, and Sterlization Compatibility
By Jan Eudy
What are the specific tests for fabric and garments? What do the results mean to the end-user?
Tech Suit Protocols: Prevention of Cross-Contamination
By Jan Eudy
Our company currently operates ISO Class 7 and 8 non-sterile cleanrooms and a sterile ISO Class 5 cleanroom that are interconnected by unclassified corridors. What can we do to prevent cross-contaminationbetween the two cleanroom areas?
Dressing For Cleanroom Success: Cutting Costs In Cleanroom Apparel
By Tony Rutt, D.J. Netz, Tony Rutt
A new level of gownroom management engages the wearers as partners in the solution.
Cleanroom Arc Thermal and Flame Resistant Garments
By Jan Eudy
What garments comply with cleanroom standards and NFPA 70E?
Implementing A Contamination Control Program
By Jeffrey Becker
The rules and special procedures needed to clean a cleanroom, and how they differ from ordinary cleaning.
Another Consideration when Evaluating Costs of an “On-Premise Cleanroom Garment Facility”
By Tony Rutt
Energy costs are a major cost component in the decision to operate an on-premise cleanroom garment facility. However, by far the largest single cost driver is labor, and the associated benefits.
Apparel System Selection For Phamaceutical Cleanrooms
By Mike Groesbeck
There are many pros and cons to consider when deciding whether to purchasesingle-use or multiple-wear garments.
Q & A on Apparel Requirements
By Jan Eudy
I am trying to better understand the product requirements specific to cleanroom apparel in the sterile and non-sterile pharmaceutical segments, globally. I have listed some specific questions that I have.
On-Premise Cleanroom Garment Facility
By Jan Eudy
What are the pros and cons of constructing an on-premise cleanroom garment laundry?