Cleaning Protocols for USP 797 Compliance
By Karen Bonnell
Using the right techniques and procedures can make cleaning sterile compounding areas a matter of routine.
Environmental Consciousness in Cleanroom Consumables Selection and Use
By Duane Webb
How can the expectations of natural resource conservation and waste elimination be achieved in highly critical cleanroom manufacturing environments?
Case Study: Exhaust Duct Decontamination Using Chlorine Dioxide Gas
By Kevin Lorcheim, Mark Czarneski
The exhaust ductwork in a laboratory at a major pharmaceutical company in North Carolina needed replacement. Since the ductwork was used to exhaust BSCs for testing on HIV and HCV, special precautions would be required during the demolition.
Green Cleaning
By Barbara Kanegsberg
Green, environmentally-preferred, sustainable, biobased, safe — the terms are sometimes used interchangeably. However, their meaning and interpretation really depend on one’s viewpoint.
The Right Extraction
By Barbara Kanegsberg, Ed Kanegsberg
For aerospace, medical, electronic, pharmaceutical, and other critical applications, direct surface analysis is not always informative or feasible. To validate cleaning, you must design and justify an appropriate extraction protocol. This involves selecting the correct extraction chemical(s) and the correct extraction techniques.
Water: A Starting Point
By John B. Durkee, Ph.D., P.E.
Back in October 2007, we wrote about how significant water is to life, and how hydrogen-bonding intermolecular forces enable that. Essential as it is, however, water alone isn’t sufficient for cleaning work. We have to add something to it, or take something away.
Water Versus Solvents Part 2: Process Trends, Selection, The Future
By Barbara Kanegsberg
In Part 2 of this montage of the cleaning industry, our experts discuss trends in cleaning processes and factors in cleaning agent selection. They then venture a look into the future.
Water Versus Solvents, Part 1: A Complex Landscape
By Barbara Kanegsberg
Twelve experts offer their viewpoints on the current state and future outlook of critical cleaning and contamination control.
Out of the Frying Pan
By Ed Kanegsberg, Barbara Kanegsberg
Solvents are used in many critical and precision cleaning processes because they are “sharp scalpels” that dissolve specific soils. However, acetone and other common cleaning agents have very low flashpoints.
Standardized Cleaning Approach For A New Pharmaceutical Compound
By J-M. Cardot, E. Beyssac
In the past, cleaning or cleaning validation problems were often pointed out by the authorities. A simple and standard cleaning approach can be used in the pharmaceutical industry in absence of specific know-how in order to initiate a reflection about cleaning.
Testing Consumable Cleanroom Products
By Jan Eudy
How do I determine if the cleanroom consumable product purchased will meet the cleanliness requirements of our cleanroom operations?
Are The Cleaning Agents Clean Enough? Part III: Solvents
By Ed Kanegsberg, Barbara Kanegsberg
For critical products, particularly products assembled in a cleanroom or other controlled environment, the purity and cleanliness of the liquids used for cleaning and assembly are every bit as important as the quality of the air.
Cleaning Methods for Ceramic Tile Floors
By Jay Glasel, Ph.D.
For removing bacterial contamination, the data shows that the spray-and-vac machine is 60 times more effective in reducing bacterial contamination than the conventional method for typical commercial floors, such as those used for aseptic processing.
Point of View: The Problem Is, We Can’t See the Problem: Or……Our Eyes Deceive Us
By Howard Siegerman, Ph.D.
Given that many companies need pristine surfaces for the manufacture of defect-free products, one might well ask why, forty years later, we should still be facing contamination issues and related product failures due to lack of proper wiping and surface cleaning?
“Non-chemical” Cleaning
By Barbara Kanegsberg, Ed Kanegsberg
A wide range of cleaning processes, commonly referred to as “non-chemical” cleaning, do not involve immersion or spray of a liquid.
How To Succeed In The Search For Nothing: Effective Swabbing Techniques For Cleaning Validation
By Wendy Hollands, Howard Siegerman, Ph.D., Michael Strauss
Searching for nothing would seem to be an absolute waste of time — unless you are responsible for cleaning validation. In that case, success is deliciously ironic since you can say, “I found nothing and that’s good news.”
Selecting The Right Agent For The Sterilization of Cleanrooms
By Paul Lorchiem, Mark Czarneski
The goal of this article is to give readers an understanding of the benefits and drawbacks of the various sterilizing/disinfecting methods with a thorough discussion of the efficacy, ease of use, and relative cost of each method.
Is This A Convenient Time To Clean?
By Howard Siegerman, Ph.D.
Asking if it’s a convenient time to clean is equivalent to asking: “Is this a convenient time to extract your impacted molars”? The simple answer is “No.”
Enclosure Washdown 101
By Mark Saunders
How food and beverage manufacturers can help ensure product and operations integrity through proper enclosure washdown procedures.
Is Your IPA Bottle Doing More Harm Than Good?
By Wendy Hollands, Allen Spivey, Lara Soltis
Study disproves misconception about contamination of sterile IPA bottles.
How To Minimize Contamination When Transferring Items Into Hospital Cleanrooms
By Suzanne Stubbs
This article will look at ways to reduce the initial bioburden on items passed into the cleanroom, so that contamination is minimized.
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.
Contract Cleaning—It's Like All Other Outsourcing
By John B. Durkee, Ph.D., P.E.
Today, contract cleaning (CC) is specialized outsourcing. This column is about why you might want to outsource this function, what choices you have, and what you should expect.
Disinfectant Rotation - A Microbiologist's View
By Scott V.W. Sutton, PH.D
A great deal of discussion revolved around the concept that a microorganism could become resistant to a disinfectant. Here is where the first bit of clarification is required. A microorganism will not become resistant to much of anything.
Health Effects of Cleaning Chemicals, Part I: What You Should Know, But Hopefully Not By Experience
By John B. Durkee, Ph.D., P.E.
Thia column and the next are a quick review of industrial hygiene—about how the human body can defend itself against bodily contact with hazardous chemicals and what happens when it doesn't.