Tag Archives: USP 797

Disinfection of Cleanroom Surfaces With Bleach

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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…]

How Do You Clean A Laminar Flow Hood?

laminar flow hood cleaning

The EasyClean® 360 is the most efficient way to clean a laminar flow hood. It’s unique triangular shaped head allows it to clean the difficult tight corners in the hood.  The tool is delivered with two handles, a 14” (35cm) and 24” (61cm).  There is also another ordering option for a telescoping handle that will extend from 35 [Read More…]

USP <797> Best Practices: Suggested Cleaning Frequency for Compounding Pharmacies

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ISO Class 5 – Primary Engineering Controls (PECs) LAFWs – BSCs – CAIs – CACIs At the beginning of the each shift Before each batch No longer that 30 minutes after previous disinfection (during ongoing compounding) After spills When a surface contaminate is known or suspected Clean area after surface sampling (i.e. Contact Rodac Agar [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 is the Best Cleaning Validation Swab?

What Is The Best Cleaning Validation Swab? The best cleaning validation swab is the LTP125S, double layer 100% polyester knit sock tip swab. This Lab-Tips® large sampling swab is an excellent choice for sampling surfaces for cleaning validation. Laundered and packaged in an ISO Class 4 (Class 10) cleanroom, it has a unique semi-flexible internal [Read More…]

Can the SatPax® 1000 Canister Be Autoclaved?

Satpax Canister

Q: Can the SatPax® 1000 canister be autoclaved? A: The canister is made from HDPE (high density polyethylene) and therefore cannot be autoclaved. The canister could melt and contaminate the autoclave chamber. It can be gamma irradiated and Berkshire would recommend 25kGy as a minimum dose.

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…]

Is There Any Latex Rubber Contained in Berkshire’s Cleanroom Products?

rubbertree

Q: Is there any latex rubber contained in Berkshire’s cleanroom products? A: Berkshire’s cleanroom consumables do not contain any natural latex rubber, which may cause allergic reactions as defined by the FDA. The latex binder that is added to the Berkshire Bond paper is 100% synthetic and does not include any natural rubber latex in its formulation.  

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…]