Critical utilities

Process Facilities 15 Area electrical classification 16 Accessibility for mechanical integrity (sampling, maintenance, repairs) 17 Protection of piping and vessels from vehicles and forklifts 18 Protection of small-bore lines, fittings from external impact, personnel 19 Routing of process piping, critical controls cable trays, critical utilities 20 Vent, drain, and relief valve discharge locations... 

VIII Appendices Useful reference materials such as maps, fire water system diagrams, critical utility emergency shut off points, names and contacts for service providers should be Included. 

Unit must he ahle to safely shutdown on loss of any critical utility. 

This involves the testing of various components of the system, process, or equipment to document proper performance of these components. This phase may include verification of acceptable operating ranges for various components or equipment, such as critical utilities. 

Controlled environment requirements Preventative maintenance Emergency repairs Validated classified areas Structural changes Cross contamination prevention General housekeeping and sanitation Cleaning agents and pest control Critical utilities... 

It is not uncommon for the FDA to assign more than one investigator to aPAI. Team inspections are most often assigned when the assessment calls for a particular kind of expertise related to the manufacturing process, analytical methods(s), processing or packaging equipment, or critical utility within the facility. 

Part 11 regarding validation of computer software and hardware. Any software used to operate process equipment, generate electronic records, track and transmit laboratory data, automate quality systems, operate critical utilities or software that is itself a medical device must be validated to ensure accuracy, reliability, consistency, and the ability to discern invalid or altered records. Where off-the-shelf software is used for any of the above cGMP activities, it must also be validated for its intended use. For additional information on compliance issues related to computer hardware and software validation refer to Chap. 7 of this book. 

If the most critical utilities used in the pharmaceutical pilot plant are those that come in contact with the product, then water is most likely at the top of the list. Water is commonly used during processing of the product and also for cleaning of equipment and process areas. Water quality can be divided into two subcategories. The first is compendial, of which there are two types, USP purified water and USP water for... 

Major equipment and critical utilities and systems, however, require IQ, OQ and PQ. 

Performance Qualification (PQ) verifies the performance of critical utility systems or processes. Critical utility systems such as WFI and Pure Steam are challenged throughout proposed operating ranges for extended periods of time, while an extensive program of quality monitoring is performed. Critical processes such as sterilization of components are challenged three (3) consecutive times under worst-case conditions. 

Alert and action levels for each parameter in each area or critical utility will be established based on the results from validation testing, compendia requirements, and cGMPs. Area or room limits will be based on the environmental data collected during the validation of the aseptic filling process validation. Specific action plans will be developed for addressing excursions beyond alert and action limits for each area or utility. 

As the human population of the earth continues to grow and the resulting crisis in world food supplies becomes more critical, utilization of wood cellulose and cellulosic waste materials as sources of food for animals or even for human consumption may become imperative. Food processors already are experimenting with fermentation methods and treatments with cellulolytic enzymes as means to increase the nutritive value of wood and other refractory food materials or waste products. It is conceivable that cellulolytic enzymes produced in microbiological cultures could be ingested by man or other animals together with foods... 

Recommendation 1. An operational security analysis program should be established for each chemical agent disposal facility to evaluate external factors (including the integrity of critical utilities) that could adversely impact continuing operability. (Tier 3)... 

Planning at TOCDF focused on high-risk systems—initially the critical utility systems the emergency generators, the uninterruptible power supply, and the HVAC system. Major upgrades on each of these systems have been made where vulnerabilities were found. A database system to track repair orders has been initiated, and plans are to incorporate this information into the TOCDF parts reorder program. 

In conclusion, the scope of what can be done for the project and engineering organization by advanced computer systems is truly wonderful, but the prudent user needs to treat all such systems critically. Utilize only those which are rigorously specified, tested on real applications (by real project people), not over-ambitious, and manifestly will pay their way in terms of a conservative business plan. There are definite cut-off points in project size and complexity below which it is not economical to operate fully integrated systems. Systems application below this threshold should not be attempted unless there are other non-economic factors such as a client who requires them (usually, for interface into overall plant information management systems). 

Kalan, A.A.E., Baina, A., Beitollahi, H., Bessani, A., BondavaUi, A., Correia, M., Daidone, A., Deconinck, G., Deswarte, Y., Garrone, F., Grandoni, F., Moniz, H., Neves, N., Rigole, T., Sousa, P., Verissimo, P. DIO Preliminary Specification of Services and Protocols. Project deliverable, CRUTIAL Critical Utility Infrastructural Resilience (2008)... 

The qualiflcation of the manufacturing equipment and control instrumentation is a prerequisite to the validation of the granulation process. Critical utilities such as purifled water, compressed air, gaseous nitrogen, etc., required for granulation are also validated to ensure that they meet the required quality speeifieation at the point of delivery to the granulation equipment. 

Loss of critical utility supply (e.g. electric power, air, fuel and water) Human error ... 

Total Plant Shutdown A total plant BSD effectively shuts down the total plant or facihty under emergency conditions. Isolation valves are closed to stop the flow of combustible, flammable, or potentially toxic fluids and to stop heat input to process heaters or reboilers, and rotating equipment. Activation of a total plant BSD should not stop or impede the operation of fire protection or suppression systems, deluge systems, sump pumps, or critical utilities such as instrument or process air. 

The EU Critical Utility Infrastructural Analysis initiative (CRUTIAL) also aims to understand interdependencies among the power and information infrastructures. Results published thus far include [10,11,12,13], all of which provide a qualitative analysis of security aspects in the power grid infrastructure. In [11], the authors present a detailed analysis of several potential intrusion scenarios in the power grid infrastructure in an attempt to raise the issue of security in the... 

Threaded piping has the following weaknesses and should not therefore be used in sizes larger than 2" or smaller than Vi in hydrocarbon or critical utility service (with the possible exception of low-temperature or low-pressure services in low risk areas) ... 

Many utilities must survive a catastrophic event such as a major explosion or fire so that emergency response systems continue to function. Yet such an incident can destroy critical utilities header containing electrical cables, cooling water hnes, and steam pipes. This is a very serious common cause effect that can trigger domino events that lead to a major catastrophe. The effect is magnified if emergency systems such as the firewater header are also damaged. 

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