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The Lead

Immediate Benefits of Real-Time Microbial Monitoring

September 17, 2014 | by Troy Tillman Sr. | TSI, Inc. | Comments

Real-time microbial monitoring provides instant information that leads to immediate benefits. Companies producing medicines and biotech products are concerned with airborne microbial contamination. They need to ensure that products and people are kept safe.

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Controlled Environments

Selecting the Cleaning System

September 19, 2014 4:34 pm | by Barbara Kanegsberg and Ed Kanegsberg | BFK Solutions, LLC | Comments

Your boss announces that you are in charge of selecting and implementing a new cleaning system. Now it is time to actually make a selection. It is a good idea to put a PQ provision into the contract for a system ... think of it as ‘lemon’ insurance.


Choosing the Right Cleanroom Shoe Covers

September 17, 2014 5:06 pm | Shoe Inn, LLC | Comments

Standard shoe covers come in a variety of materials; variations come in the form of different thicknesses, combinations, traction patterns, etc. With so many available options, how does a cleanroom/facility manager select the right shoe cover?    


Implementing Gowning Guidelines For Proposed USP <800> Compliance

September 17, 2014 4:37 pm | by Peter Lojac and Kenneth Latta | Comments

Increasing concerns regarding the protection of healthcare workers, compounding pharmacists, and manufacturers handling hazardous drugs has bought about the proposed USP Chapter <800> – Hazardous Drugs – Handling in Healthcare Settings. Due to the harmful consequences of improper handling of these drugs, it is vital that a safe standard be set to ensure safety and efficiency.


Not All Gloves Are Created Equal

September 17, 2014 4:14 pm | by Derek Watts | Nitritex Canada Limited | Comments

When choosing gloves for your pharmaceutical manufacturing in an ISO Class 4, 5, or 6 cleanroom, why should you always choose cleanroom gloves and never surgical gloves? A common misconception is that gloves used in medical environments are sterile - but they are not necessarily clean.


Managing Data in Food Safety Cleanrooms

September 17, 2014 4:14 pm | by Colin Thurston | Comments

Cleanrooms play an important role in the prevention of contamination during the production of food and food supplements. They are most often built around food packaging processes, where there is a high potential for exposure of the finished food product to the atmosphere or people. A LIMS tracks real-time information about the cleanroom and offers the ability to demonstrate compliance.


Trends in the Biotechnology Industry

September 17, 2014 2:59 pm | by Members of ISPE’s Biotechnology Community of Practice | ISPE | Comments

Changing regulations and rising costs put pressure on cleanroom facilities.                                    


Cleanroom Safety and PPE

September 17, 2014 1:49 pm | Comments

A cleanroom safety program should define how the PPE (personal protective equipment) or cleanroom garments are worn to enhance operator safety. Here are some examples of safety criteria for hoods, masks, goggles, coveralls, and booties.

Develop Your Cleaning Scorecard

September 16, 2014 12:52 pm | by Mike Jones | Comments

Playing the cleaning game means tallying up the costs and benefits.                                         


Upping Your Game

September 16, 2014 12:09 pm | by Patrice Galvin | Controlled Environments Magazine | Comments

Cleaning is the name of the game in this issue of Controlled Environments. This issue features our annual Company Profiles, as well as articles on selecting and purchasing a new cleaning system; corrosion of stainless steel caused by bleach; LIMS in the food and beverage industry; new regulations in the biotech sector; the ever-present need for microbial monitoring; and hazardous production materials.


Are You A Reluctant Leader?

September 16, 2014 11:34 am | by Walt Grassl | Comments

Some people are very comfortable doing a job that has no leadership dimension, even though they may thrive as a leader. This condition is sometimes referred to as Altitude Sickness. When assessing your teams, use these five signs to look for the quiet, unambitious employees who demonstrate the qualities of reluctant leaders and help cure them of their altitude sickness.


Mind Reading for Managers

September 2, 2014 4:56 pm | by Kim Seeling Smith | Comments

Countless companies dedicate a sizeable chunk of their annual budgets to solving their employee engagement issues, when in reality most engagement issues (as well as performance and behavioral problems) can be solved through conversation. Five conversations to be precise. 


Immediate Benefits of Real-Time Microbial Monitoring

August 15, 2014 12:14 pm | by Troy Tillman Sr. | TSI, Inc. | Comments

Real-time microbial monitoring provides instant information that leads to immediate benefits. New technology, such as real-time viable particle counters, measures viable particle counts as they occur. Quality Control utilizes alert and action limits for reactive and corrective activities. In Quality Assurance, attention is placed on trending data, process improvement, and preventative actions.


Cleaning System Selection

August 15, 2014 11:34 am | Comments

There are many factors to tabulate when selecting a new cleaning system. The first recommendation is always to try to pass the job to somebody else. Failing that, use a ’cleaning scorecard.’ Using standard statistical tools, engineers can model all the operating costs for systems of different types and sizes.


Portable Air Conditioner Addresses Cleanroom Cooling Challenge

August 11, 2014 8:36 am | by Clark Michel | Comments

Portable air conditioning is a popular choice when installed HVAC equipment is offline for refurbishment or repair. When the space being served is a manufacturing cleanroom, the temporary cooling requirements become more complex. 


Fixture Styles for Cleanroom Lighting

August 10, 2014 7:33 pm | Comments

The need for multiple air filters in cleanroom facilities leaves minimal space for light fixtures. There are three common fixture styles for cleanrooms that maximize the use of the space: recessed troffers, surface-mount fixtures, and surface-mount teardrop fixtures. These are best-suited for use in cleanroom facilities, depending on ISO classification.



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