Tag Archives: Medical Device

Endotoxins: A Danger to Pharmaceutical & Medical Device Manufacturing Industries

Bacteria low endo

Introduction Pharmaceutical and medical device manufacturing personnel must cope with endotoxins – a contamination source unique to their industries.  Endotoxins, also known as pyrogens, originate from dead (!) gram negative bacteria. When this strain of bacteria are killed by antibacterial reagents (say phenolic or quaternary ammonium compounds), radiation, steam sterilization, etc. the cell wall detritus [Read More…]

Disinfection of Cleanroom Surfaces With Hydrogen Peroxide

Disinfection of Surfaces with Hydrogen Peroxide

Disinfection of Surfaces with Hydrogen Peroxide Of all the contamination control activities in a cleanroom, perhaps the most critical are disinfection procedures. That’s because human health depends on the quality and thoroughness of a surface disinfection wipedown. Many solutions can be considered for surface disinfection, but hydrogen peroxide and sodium hypochlorite (bleach) rate special attention. [Read More…]

Disinfection of Cleanroom Surfaces With Bleach


A previous article in this series discussed disinfection of surfaces with hydrogen peroxide.  We turn our attention now to bleach as another very effective treatment agent. Most people understand that ordinary household bleach – a 5.5% solution of sodium hypochlorite (NaOCl) in water – is a strong disinfecting agent.  In neutral or slightly acidic solutions the active [Read More…]

Cleanroom Paper vs. Standard Copy Paper

cleanroom paper BCR bond

  BCR® Bond 850 100% wood pulp, synthetic latex binder Helmke Drum (particles/ft3) : 68 Na+ : 100ppm K+ : 1.7ppm Ca++ : 0.56ppm Mg++ : 0.13ppm Cl : 44ppm Standard Copy Paper 100 % wood pulp Helmke Drum (particles/ ft3) : 7200 Na+ : 1500ppm K+ : 12ppm Ca++ : 180ppm Mg++ : 61ppm Cl : 2000ppm   68ppm Vs. 7200ppm! IEST – [Read More…]

What is the Best Gamma Irradiated Cleanroom Mop?

What Is The Best Gamma Irradiated Cleanroom Mop?

Q: What is the best gamma irradiated cleanroom mop? A: BCR® Mop Head 4 is laundered and packaged in Berkshire’s ISO Class 4 (Class 10) cleanroom.  It is made of 100% knitted polyester. The mop head features a tubular knit construction with fan-tailed looped ends which minimizes particle and fiber generation. A Certificate of Irradiation for traceability is [Read More…]

What Does AAMI Stand for?

quality assurance

AAMI is the Association for the Advancement of Medical Instrumentation. Berkshire’s line of Gamma Wipe® cleanroom wipes are gamma irradiated and validated sterile to a 10-6 Sterility Assurance Level (SAL) per AAMI guidelines. Did you know? – The International Organization for Standardization (ISO) defines Sterility Assurance Level (SAL) as the “probability of a single microorganism occurring on an [Read More…]

Do CapSure® Wipers Leave a Residue on Surfaces?

Capsure logo

Q: Do CapSure® wipers leave a residue on surfaces? A: CapSure® treated wipers are not tacky, sticky or stiff and will not leave a residue on surfaces being cleaned. The patented (#8,431,497) surface treatment enables the wiper to capture and retain more particulate contamination than untreated wipers. The color, surface texture and hand of the laundered knit [Read More…]

Cleanroom Wipers: Where Are Irradiation Dots Located and What Do They Mean?

Young scientist while using digital tablet at laboratory.

Q: Cleanroom Wipers: Where are irradiation dots located and what do they mean?  A: Irradiation indicators (dots) are not an indication of sterility. They indicate that product has been exposed to irradiation. The color changes from yellow to red due to a shift in pH. Indicators are typically placed on the outer packaging (on the case) for [Read More…]

What is the Shelf Life of a Berkshire Sterile Cleanroom Wiper?

A three-year shelf life has been identified for both Berkshire’s dry and presaturated sterile wipers. The expiration date is located on each pack and case label and also on the Certificate of Sterility. A Certificate of Sterility is placed in a separate shipping label pouch which is attached to the outside of every carton of [Read More…]

Is The Validation Process The Same For Sterile Pre-Saturated Vs. Sterile Dry Wipes?


Is the validation process the same for sterile presaturated vs. sterile dry wipers?  Yes, the validation process is the same for presaturated vs. dry as they both follow ANSI/AAMI/ISO 11137, Sterilization of Health Care Products.  The product is saturated, packaging is sealed and then the cases are sent to be irradiated. The cases are irradiated wet. [Read More…]