Pharmaceutical equipment requirements

Commercial products, high pressure applications in, 13 436-438 Commercial-scale pharmaceutical operations, 13 733-736 in-process controls in, 18 734 processing equipment requirements in, 18-733-734... 

ABC Pharmaceutical Industries information. The equipment preparation pages of the master batch record specify the validated sterilization processes to be employed in the preparation of the equipment for (product name) USP. Cycle sterilization parameters are defined along with attributes such as loading patterns and the mechanics of operating the sterilizing equipment. The following lists the sterilization cycles utilized for the equipment required in the processing of (provide product name) USP ... 

Facilities and Equipment The technical experts who have an understanding of pharmaceutical science, risk factors, and manufacturing processes related to the product are responsible for defining specific facility and equipment requirements. The equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination and product mix-ups. It is important to remember that the GMPs place as much emphasis on process equipment as on testing equipment while most quality systems focus only on testing equipment. Control Outsourced Operations Quality systems call for contracts with outside suppliers that clearly describe the materials or service, quality specification responsibilities, and communication mechanisms. 

Air removal is particularly important in porous and equipment loads, but is usually of little importance in the sterilization of aqueous pharmaceutical products. Air removal can be important to the specification of new autoclaves—those which are to be designated only for aqueous product sterilization have no need for the pumps and ancillary equipment required to pull deep vacuums. 

Custom-built control cabinets are provided for various types of pharmaceutical equipment, usually by the equipment manufacturer. These control cabinets should be UL listed or labeled, otherwise all of the wire and electrical equipment in them are subject to the requirements of the NEC. The functions controlled by these control cabinets and sometimes the equipment within the control cabinets and all of its control circuits should be part of the qualification and validation process. 

Viscosity relates to the internal friction within the fluid which is caused by intermolecular interactions and is therefore important in all physical processes which involve the movement of the fluid or components dissolved within it. Therefore the design of liquid-liquid extractors, distillation columns, heat-transfer equipment, process piping, reactors, and other units found in various chemical and pharmaceutical industries requires the knowledge of the viscosity of fluids and their mixtures. 

It is important to match mixing equipment capabilities with process requirements. While it is desirable to have an optimum design and operating conditions for every step in the process sequence, it is seldom practical to do so. For example, specialty and pharmaceutical processes require the use of multipurpose reactors. An important consideration is to understand how less-than-ideal equipment wiU function in aU stages of operation. 

As the commercial chemical industry has spread around the world in response to the urgent needs of developing countries for chemical fertilizers, pesticides, and pharmaceuticals, the availability of chemicals and equipment required to produce CW agents has increased. At the same time, thousands of applied organic chemists and chemical engineers from developing countries have been trained in related production technologies at universities in the United States, Europe, and the former Soviet Union. 

The outfitting with instruments and other pharmaceutical equipment must fulfill the requirements on quality and safety of the medications prepared. 

The equipment required for water treatment will be determined by the quality of the incoming water. Typically, a USP pharmaceutical grade system will require pretreatment (filters), deionization, reverse osmosis, and potentially a polishing step such as continuous deionization. Many systems now incorporate UV filters for sanitization, which kill micro-bials and also eliminate ozone. 

The requirement that equipment should be tested and proven to be fit for purpose is effectively fulfilled by an approach known as equipment qualification (EQ), which is well established and proven in the highly regulated pharmaceutical industry. EQ is complementary to method validation for the spectrophotometer and is built on effective instrumental calibration validation (see below). EQ is a systematic procedure, which ensmes that suitable equipment is purchased and that it remains fit for its chosen purpose throughout its operating life. The same requirement is present in ISO/IEC 17025, where section 5.5.5 Records of Equipment requires checks to ensure compliance with the specification, maintenance plans, etc. 

This chapter is about the design, quality and application of equipment for the preparation of medicines in a pharmacy or for preparation in small scale pharmaceutical industry. The type of pharmaceutical equipment needed depends on the type of products to be produced, on the required productive capacity and the batch size. A list of essential and critical equipment for production and quality control must be included as attachment in the URS (User Requirements Specification) of any facility. In this chapter only equipment commonly used for preparation in pharmacies and small scale industry is discussed. The equipment, requirements, qualification methods, main applications, maintenance and cleaning procedures are described for ... 

It is also a guideline to ensure product quahty through the suitabihty of the manufacturing equipment, air and water quahty, sanitation, insect and rodent control, and housekeeping. The FDA periodically sends inspectors to audit chemical companies who manufacture bulk pharmaceutical chemicals or inactive ingredients called excipients to ensure conformance. Whereas GMP conformance ensures that the product meets pharmaceutical quahty standards, it does not ensure conformance to customer-service-related requirements. 

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