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.
For a controlled environments facilities engineer, hazardous production materials are not the...
Bleach is known to be corrosive to metals commonly found in pharmaceutical work environments....
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.
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?
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.
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.
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.
Changing regulations and rising costs put pressure on cleanroom facilities.
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.
Playing the cleaning game means tallying up the costs and benefits.
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.
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.
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.
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.
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 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.
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.