FACILITY DESCRIPTIONS

The first step in the development of an SMS is to describe the facility for which 

ABC Pharmaceutical is a medium-sized pharmaceutical industry in New York state and employs approximately 500 employees. The plant intends to produce millions of units annually. The annual sales of the plant are above U.S. 200 million. The total covered area is 50,000 square feet. ABC Pharmaceutical places basic emphasis on the concept of quality and on strict compliance with the rules of current Good Manufacturing Practice (cGMP) in all steps of manufacturing, shipping, and marketing. 

The Head Office of ABC Pharmaceutical is located at Kennedy Airport Road, approximately 60 km east of New York City, New York, U.S.A. 

Building A of ABC Pharmaceutical is designed to manufacture dry oral products. The conventional pharmaceutical dosage forms include tablets, capsules, and powders for suspension. 

Building C is designed to manufacture injectables in ampoules, vials, and disposable ready-to-use syringes, and lyophilized products in vials. 

---

Large Scale Integral Tests—Facility Description, DIERS/ AIChE, 1986, 48 pages. 

SYSAF GasTeF facility description - http //ie.irc.ec.europa.eu/at a glance/facilities.ohp... 

Manufacturers of resins, colorants, inks, compounds, parts, molded components, container systems, and packaging operations all use Type 3 DMFs. Depending on the subject of the DMF, it should contain the following A short facility description, the formulation providing the trade name, the generic name. Code of Federal Regulations Title 21 indirect food additive reference or Food Contact Number, Chemical Abstract number, and references to other supporting DMFs, if applicable. The DMF should list... 

Facility description. The facility description addresses locations, numbers of employees covered and uncovered in area, specificity of processes and line capacities, etc. 

Documentation format of qualification programs Numbering system Revalidation Facility description Description of building... 

Most of the exohedral fullerene derivatives of preparative importance are formed by one or several formal 1,2-additions to [6,6]- or [5,6]-bonds. For a suitable discussion of the regiochemistry of such fullerene derivatives it is very valuable to introduce a simple and clear site labeling system, which allows facile description of the constitution of a given fullerene derivative. We first introduced a very descriptive nomenclature [177,188] for the assignment of the relative positional relationships (like ortho, meta and para in benzene chemistry) of addend carrying bonds in Cgg derivatives with labeling the corresponding bonds as cis-n (n = 1 -3), e, e", trans-n (n= 1-4) (Fig. 15). 

Thimsen, David et al.. Fixed Bed Gasification Research Using U.S. Coals Vol. 1 Program Facility Description, USBM H0222001. McClennen, W. H. Meuzelaar, H. L. C. Metcalf, G.S. Hill, G. R. Fuel 1983, 62, 1422. 

Figure 14 An Example of Facility Description Language in ROBCAD System.

DOE-STD-3009-94, Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Safety Analysis Reports, describes a SAR preparation method that is acceptable to the DOE. Chapter 2 of the Standard presents the format and content required for the facility description contained in the SAR. (DOE 1994b). 

All operations with loose radioactive materials occur in sealed confinement structures, such as the Room 113 gloveboxes, the SCBs, the Steel Transfer Box (STB), or under the Room 113A fumehood. These confinement structures are well ventilated and the exhaust filtered through the HCF "hot" exhaust system. (See Chapter 2, "Facility Description," for a discussion of these and other facility design features that limit the spread of contamination.)... 

Facility description should include the following type and location of facility, type of population served, essential services, types of care offered, size of facility, and the number/ distribution of beds. 

The Facility Description section of the safety case approach is designed to assist in iderrtilying areas where specificatiorts are critical. See DISK (2000) in Frrrflrer Reading at the end of this chapter. 

Once the facility description is complete and technical information has been gathered, the next step in the development of an SMS is to conduct a risk assessment. Such an assessment consists of five steps ... 

All three elements must be linked to one another. For example, the facility description will provide technical information that provides the basis of the formal safety assessment and the safety management system. Similarly, the safety management system will define what information should be included in the facility description. 

---