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Related post: result in cross-contamination problems. For example, removal of the cake from penicillin fermentation equipment could result in airborne contamination from partly dry or dry cake. With regard to the respondent's second example, the Commissioner is revising this requirement to make it apply only to production operations and not to storage, such as warehousing of the Purchase Triamcinolone Online penicillin product in sealed containers. 148. Comments were made that proposed 211.46(e) was superfluous because 211.42(d) already required separate facilities for penicillin and nonpenicillin products. The Commissioner believes it is important to make clear in these regulations that completely separate air handling facilities for penicillin and nonpenicillin production are required. Section 211.42(d) is written to allow penicillin production in the same buildings as nonpenicillin production if the penicillin production areas can be completely separated from all others. However, because it is possible for air-handling systems between penicillin and nonpenicillin production areas to be interconnected, the Commissioner finds it necessary to state that any such interconnection would be unacceptable. 149. One comment said proposed 211.46(e) should specify whether the air- handling system is intended for outgoing or incoming air. There is no single answer to this point since the specific requirements for a particular installation will depend on individual circumstances. The purpose of the requirement is that no cross-contamination occur between penicillin and nonpenicillin operations. The means by which the objective is achieved may require filtration of incoming air of Buy Cheap Triamcinolone filtration of outgoing air or both. PLUMBING 150. A number of comments on 211.48(a) said water received from municipal sources and certified as meeting the requirements of Subpart J of 42 CFR Part 72 should not have to be tested as if it were another component. It was not the Commissioner's intent that potable water received from municipal sources require Triamcinolone Creme acceptance testing by a drug manufacturer unless the water is obtained from sources that do not control the water quality to assure compliance with Public Health Service standards. Of course, water of unknown quality such as a firm's own wells must be tested, and potable water coming into the plant system should not be adversely affected by the in-plant plumbing. 151. A number of comments indicated that it is not necessary and is Triamcinolone Lotion very expensive to require that all water in a plant be potable water. They pointed out that some systems such as sprinklers for fire control, cooling equipment, and Buy Triamcinolone boiler feed do not require potable water. In light of these comments, the Commissioner is revising 211.48(a) to eliminate the prohibition against nonpotable water within a plant. 152. One comment said potable water should be analyzed for polychlorinated biphenyls and chloroform, and tolerances should be set because of the potential danger to health represented by these contaminants. The Commissioner recognizes that potable water may contain amounts of environmental chemical contaminants at levels that have not been clearly established as having significant adverse effects when ingested. Government agencies are investigating more meaningful specifications for testing potable water for potentially harmful impurities not already included in the standards. Therefore, FDA has not included such requirements for testing and acceptance of potable water in these regulations. 153. Several comments objected to the designation of traps to prevent back- siphonage in 211.48(b). The comments said it is general opinion that traps do not prevent back-siphonage, but check valves or air break arrangements would do so. The Commissioner agrees with these comments, and 211.48(b) is revised to reflect the suggested change. 154. One comment objected to equipping drains with traps because of the inflationary impact and requested that this Triamcinolone 0.1 paragraph be deleted. The Commissioner notes that this paragraph is revised to eliminate the reference to traps. It now Cheap Triamcinolone requires the use of air breaks Order Triamcinolone or other mechanical device which may increase or decrease the cost to this person, depending on his present method of preventing back-siphonage. However, the Commissioner considers that the necessity of preventing back-siphonage outweighs the cost factor. WASHING AND TOILET FACILITIES 155. Several comments on 211.52 Triamcinolone Online argued that it is not current industry practice to provide "hot" water, but rather to provide "tempered" water, thus conserving energy while maintaining adequate sanitation facilities. The Commissioner has been unable determine that there is a consensus as to what is meant by "tempered water." Therefore, he is concerned that the word "tempered" might allow the use of water that is of insufficient temperature for adequate Generic Triamcinolone cleaning. 156. A comment suggested that the word "easily" be deleted from 211.52 because location of washing facilities may be hindered or prohibited by local plumbing codes. Further comment said the word "easily" Purchase Triamcinolone is most subjective and capable of differing interpretation. The Commissioner is not convinced that plumbing codes would prohibit easily accessible washing facilities in establishments that are properly designed. Further, the Commissioner believes that the word "easily" is concise Triamcinolone Ointment enough to adequately describe the intent of the section. Therefore, the wording as proposed is retained in the final regulation. ANIMAL FACILITIES 157. Several comments contended that proposed 211.54 should be deleted since it substance is covered by the Animal Welfare Act of 1970 (Pub. L. 91-579, 7 U.S.C. 2131). Other comments said this section implies that housing for laboratory animals is required whether or not a firm maintains laboratory animals. The Commissioner does not believe it is improper to make the substance of another regulation a requirement in th CGMP regulations. It should be Order Triamcinolone Online obvious that if a firm is not engaged in a type of operation covered by these regulations, then any requirement that pertains to that type of operation does not apply to that firm. In reviewing this proposed section, however, the Commissioner has concluded that its intent is adequately covered in 211.173. Therefore, 211.54 is deleted in the final regulation. SANITATION 158. Several comments on 211.56(a) said it is impossible to maintain all buildings completely free from rodents, birds, insects, vermin, trash, and organic decaying matter. Triamcinolone Cream In most buildings there is an accumulation of trash daily in various waste baskets and in trash accumulation areas for papers and empty cartons. The Commissioner agrees that the intent of this section could be more clearly stated, and the text is revised accordingly. 159. Several comments requested the deletion of the phrase "in detail" from 211.56(b), because, according to the language in this paragraph, manufacturers would be required to document all minute details. The Buy Triamcinolone Online Commissioner believes that in some cases, detailed descriptions of cleaning procedures may be necessary to assure complete and proper cleaning. In others, that level of detail may not be necessary or appropriate. The Commissioner believes that there should be a reasonable standard in describing the details of these procedures. Therefore, this paragraph Acetonide Triamcinolone is revised to require "sufficient" detail.
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