For complex organizations, such as pharmaceutical companies, the importance of a disaster recovery strategy can’t be overstated. Controlled Environments recently spoke with Chris Burgher, Business Development Executive at SunGard Availability Services, Wayne, Pa., about how organizations can prepare for unexpected business disruptions.
A mini-environment enhances the cleanroom setting by bringing it to a higher standard.
The recent revisions of the GFSI (Global Food Safety Initiative) standards and the FDA rulings to implement the Food Safety Modernization Act have increased the requirements for controlled environments to prevent contamination of high risk foods and high care areas.
Water is the fluid most often used in cleaning, whether it is for personal, household, industrial, or the manufacture of high-value product. Water is the most abundant cleaning chemical. With appropriate additives, water-based cleaning has proven successful. However, particularly in critical manufacturing, the wrong water quality can derail the process and undermine product quality. How do you get water to the right quality?
Contamination control is vital for maintaining cleanroom environments. Pharmaceutical and semiconductor companies require especially stringent maintenance and sanitation programs to meet demanding standards for air quality, room design, and operation, such as those set by the International Organization for Standardization.
In some respects, the insulation traditionally used in cleanroom manufacturing is like those 1980s-era cellular phones—much too clunky and somewhat prone to performance problems. But then, the conventional open-celled polyethylene foam insulation used in cleanrooms dates back to the 1980s or earlier.
Sustainability is defined as meeting the needs of today without compromising the ability for the next generation to meet theirs. Today, many manufacturers have begun practicing green initiatives such as environmental management systems (EMS) and complying with ISO 14000 standards.
Letter From the Editor - September 2013
New guidance represents the most recent example of the FDA’s commitment to the principles of QbD. Ever since the FDA issued its landmark guidance Pharmaceutical GMPs-A Risk Based Approach in 2004, the industry has been struggling with how to demonstrate process understanding as a basis for quality.
Chemicals have the potential to interact with the product, and not always in a desirable manner. Chemicals are essential to the manufacturing process. We have to strike a balance between the desirable function of the process fluid or cleaning agent and the potential for damage to the product being fabricated.
While usually under the purview of an Environmental Health & Safety department, the facilities department can’t ignore its role in maintaining a safe workplace. Today’s controlled environments present an obstacle course of varied safety challenges for the facilities professional ranging from the benign to the life threatening.
Improper air velocity rates can put a cleanroom at risk. Accurate measurement of airflow in a cleanroom is vital to making sure that the facility is up to code and functioning properly. Precise air velocity measurement can be used to reveal proper or improper performance of an airflow system, and steps can be taken from there to correct any potential problems.
Cleanroom lighting design should provide the right amount of illumination while also being appropriately gauged to the cleanroom classification. While lighting for cleanrooms should be energy efficient and provide proper illumination for the task at hand, it is crucial that lighting coordinates with air-supply systems and minimizes any chances for contamination.
Selecting an appropriate adiabatic humidifier can result in energy efficiency, worker comfort, and increased productivity. Air conditioning, heating, and fresh air intake during winter conditions and dry summer months cause electrostatic discharge in cleanroom environments.
The future processes and facilities will be driven by the product, and by economic and regional parameters, but the key will be flexibility. With an increasing diversity of therapies and drug product ranges, facility designs also require diversification.