Equipment facilities

The layout should ensure that exhausts are not placed close to fresh air intakes and that fire sprinkler protection for present and future requirements, eg, under stairs, storage racks, overhangs, covered walks, etc, is available. AH facility equipment must be stmcturaHy secured as well as freeze protected. 

Processing and Recovery The functional element of processing and recoveiy includes all the techniques, equipment, and facilities used both to improve the efficiency of the other functional elements and to recover usable materials, conversion products, or energy from solid wastes. Materials that can be recycled are exported to facilities equipped to do so. Residues go to disposal. 

The system consists of procedures for controlling personnel, facilities, equipment, and communications. 

The standard requires suppliers to utilize appropriate mistake-proofing methods during the planning of processes, facilities equipment, and tooling. 

In many cases these requirements will not apply but in some contractual situations the customer may provide products or services for use by the supplier in connection with the contract. This clause of the standard specifies requirements that apply in such situations. The product being supplied may have been produced by a competitor, by the customer, or even by your own firm under a different contract. These requirements apply to any product supplied to you by your customer and not only to what is to be incorporated into supplies. The customer may in fact supply facilities, equipment, software, or documentation for use in conjunction with the contract, which may be provided on loan, to be returned on completion of the contract or to be retained. Customer-owned tooling and returnable packaging also constitutes customer supplied product. If you use the customer s facilities, such use should be governed by the regulations imposed in the contract rather than these requirements. If the customer supplies documentation, unless it is required to be returned, you should assume it is yours to keep. Such documentation is not governed by these requirements although, if the customer requires the documents to be returned, you should assume that these requirements do apply, but apply them with discretion. 

To promote uniformity in area classifications for oil and gas drilling and producing facilities, the American Petroleum Institute developed RP 500, Recommended Practice for Classification of Locations for Electri cal Installations at Petroleum Facilities Classified as Class 1, Division 1. and Division 2. Figures 17-4 to 17-14 show some common recommended classifications surrounding common production facility equipment as given in RP 500. API RP 500 also provides valuable tutorial information on the philosophies of area classification and the reader is encouraged to become familiar with this publication. 

Infrastructure (Provide facilities, equipment, and support services)... 

Collectively, the combination of appropriate facilities, equipment, documentation, manufacturing practices and quality control procedures provide a basis for effective product and process control. This is illustrated in Figure 11.10. 

Infrastructure - Provide appropriate facilities, equipment and supporting services... 

A description of the facilities equipment and quality control arrangements at the site. 

Cross-disciplinary partnership awards Equipment and Facilities Equipment and instrumentation grants Regional and national equipment facilities... 

The goal of tocolytic therapy is to postpone delivery long enough to allow for administration of antenatal corticosteroids to improve pulmonary maturity and for transportation of the mother to a facility equipped to deal with high-risk deliveries. 

Consideration should be given to use the general prevailing environmental conditions such as wind and terrain elevation to best advantage for spill and vapor removal. Facility equipment should not be located where they would be highly vulnerable to a major spill or vapor release. 

Adequate safety and reliability have been incorporated into the design, construction, operation, and maintenance of any installation, storage facility, equipment, and infrastructure connected with its operation which are linked to major-accident hazards inside the establishment. 

Facilities for handling test and control articles Laboratory operation areas Specimen and data storage facilities Equipment design... 

Appropriate personnel, resources, facilities, equipment, materials, and methodologies must be available. 

Design Qualification (DQ) This provides documented verification that the design of the facilities, equipment, or systems meets the requirements of the user specifications and GMP. 

Regulatory authorities recognize that, in spite of all the control systems put in place, deviations and changes are sometimes inevitable. A robust GMP system includes procedures to handle, review, and approve changes in raw materials, specifications, analytical methods, facilities, equipment, processes, computer software, and labeling and packaging. All the changes have to be documented with references for traceability. 

The principles of Good Laboratory Practice are complied within its laboratory, a Laboratory Policy exists and it is communicated and understood by the laboratory personnel, a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available in the laboratory and proper training and relevant ... 

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Manage patients receiving the drug in facilities equipped and staffed with adequate laboratory and supportive medical resources. 

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use sirolimus. Manage patients receiving the drug in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information needed for the follow-up of the patient. Liver transplantation-excess mortality, graft loss, and hepatic artery thrombosis (HAT) The use of sirolimus in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant recipients. Many of these patients had evidence of infection at or near the time of death. 

Anaphylactic or anaphylactoid reactions may occur following administration of any dose or course of muromonab-CD3. Serious and occasionally life-threatening systemic, cardiovascular, and CNS reactions have been reported. These have included the following Pulmonary edema, especially in patients with volume overload shock cardiovascular collapse cardiac or respiratory arrest seizures coma. Hence, a patient being treated with muromonab-CD3 must be managed in a facility equipped and staffed for cardiopulmonary resuscitation. 

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