Equipment design, documentation

Engineering design, chemical reactivity hazard management, 23 Equipment design, documentation, 105 Equipment sizing, risk assessment, 95 Existing management systems, chemical... 

Process definition and design criteria Process and equipment design Company memory (management information) Documentation of risk management decisions Protective systems Normal and upset conditions Chemical and occupational health hazards... 

Process documentation and knowledge Documentation of hazards, equipment design, risk management decision, etc. applies... 

All stages of antibiotic manufacture from fermentation through to finished product are governed by the code of good manufacturing practice (GMP), of whieh quality eontrol is one aspect. GMP requires that there should be a eomprehensive system, so designed, documented, implemented and controlled, and so furnished with personnel, equipment and other resourees as to provide assuranee that products will consistently be of a quality appropriate to their intended use. ... 

Process equipment design and materials must be documented by identifying the applicable codes and standards (e g., ASME, ASTM, API). If the codes and standards are not current, the DOE contractor must document that the design, construction, testing, inspection, and operation are still suitable for the intended use. If the process technology requires a design that departs from the applicable codes and standards, the contractor must document that the design and construction are suitable for the intended purpose. 

Process Knowledge and Documentation—The main features here are process definition and design criteria, process and equipment design, company memory (management information), documentation of risk management decisions, protective systems, normal and upset con-dtions, and chemical and occupational health hazards. 

All the equipment qualification documents must define the equipment designation, tests to be performed, test specifications, materials, operators, reviewers, and responsibility for approval. 

The Installation Qualification consists of a description of the lyophilization equipment, a system hardware and component list, the documentation of the installation procedures, and the equipment start-up and operator training. The IQ also includes references to the purchase specifications, engineering review, and SOPs. The objectives are to assure that the equipment design and construction are appropriate for the intended use, it is installed properly, the utilities are suitable and adequate, and that procedures are in place for proper maintenance and operation. 

Some pharmaceutical and healthcare companies give their suppliers a relatively free hand, while others may impose particular equipment and design requirements. A closer examination of any imposed constraints will often expose the fact that preferred equipment and design are not, in fact, critical. Indeed, a measure of choice in the details could be delegated to the supplier and recorded in the design documentation. 

The Functional Specification should, as far as possible, avoid detailed design and concentrate on defining the operation and user interaction with the computer system. This is generally more difficult than it sounds. In some instances it is not even applicable because the URS specifically requests particular equipment or a particular design to be used. Similarly for small projects, it is often more convenient to combine the Functional Specification and Design documents into what is often referred to as a Functional Design Specification, System Definition, or System Description. 

Functional specifications should be developed for the host machine, its operating system, and utilities. The scope will include the use of any servers. Design documentation should cover the actual configuration and semp of the computing hardware and associated equipment. 

OQ verifies that the control and monitoring instrumentation, as integrated with the process equipment and any associated computerized control system, meets the operational and functional requirements defined in the instrument application design documentation and/or computerized control system User Requirements Specification (URS). PQ verifies that the control and monitoring instrumentation, as integrated with the process equipment and any associated computerized control system, meets the operational and functional requirements defined in the instrument application design documentation and/or computerized control system URS, and prodnces pharmaceutical product consistently to specification. ... 

Equipment specifications are detailed design documents that describe the requirements and procedures for vendors to quote on a piece of equipment. The following list outlines the requirements and information that should be formatted in an equipment specification ... 

There are various types of analyses that are used for a process hazard analysis (PHA) of the equipment design and test procedures, including the effects of human error. Qualitative methods include checklists, What-If, and Hazard and Operability (HAZOP) studies. Quantitative methods include Event Trees, Fault Trees, and Failure Modes and Effect Analysis (FMEA). All of these methods require rigorous documentation and implementation to ensure that all potential safety problems are identified and the associated recommendations are addressed. The review should also consider what personal protective equipment (PPE) is needed to protect workers from injuries. 

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