Equipment selction gmp


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3 Selection Purchase specification Maintenance Cleaning

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Selection 4 EQUIPMENT DESIGN, SIZE, AND LOCATION: The effectiveness of equipment, like the quality of a product, starts at the design stage. When evaluating alternate types or makes of equipment, several parameters need to be considered : 1 . Operating criteria are adequate for the process—size, speed, effectiveness. 2 . Availability of spares and servicing . This can result in using different makes of equipment in different parts of the world . Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

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3 . Maintenance . The frequency and ease of maintenance will significantly impact on productivity and even quality. Equipment breakdown during processing could adversely affect quality. 4. Construction materials and design 5 . Availability of process controls such as automatic weight adjustment on tablet presses and temperature recorders on ovens. 6. Cost . A comprehensive cost should be compiled which will include the base price plus any additional costs. 7. Availability of design and maintenance manuals from the supplier that are important for validation/qualification and maintenance programs. New equipment should not be used for commercial production until it has been qualified and the process in which it is to be used has been validated. 4


EQUIPMENT CONSTRUCTION: 6 Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. The manufacturer should determine which drug products and materials are to be processed in the equipment and where contact between materials and machinery occurs. Since many of the surfaces of processing equipment are either stainless steel or glass so this is not too great risk. However , stainless steel is not totally inert and care should be exercised in choosing the grade—note that distilled water is very corrosive and requires 316 grade, which should then be passivated, usually with 15–30% nitric acid.

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Evaluation of potential interactions will include introduction of unacceptable extractives from the equipment into the product, alteration of the physical or chemical properties of the product, and introduction of particulates from abrasion of surfaces . Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. This requirement affects the design, construction, and placement of manufacturing equipment. Motors, drive belts, gears, and other potential sources of lubricant contamination should be located away from vessel or package openings that could result in product contamination. 7

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8 For equipment where this is not possible, such as some mixers and tablet and encapsulating machines, lubrication needs to be controlled and monitored; buildup of lubricant and powdered product should be regularly removed and lubricants should be of food grade. Gaskets and other connecting surfaces should be monitored to ensure they don’t break down, thereby allowing environmental contamination or gasket particles into the product


EQUIPMENT CLEANING AND MAINTENANCE Equipment shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. Written procedures shall be established and followed for cleaning and maintenance of equipment, used in the manufacture, processing, packing, or holding of a drug product. two reasons for cleaning, maintenance and sanitation. First, to prevent contamination from materials previously utilizing the equipment. The second reason is an acknowledgment that inadequate cleaning or maintenance may cause equipment to malfunction or break down and that this could have an adverse effect on the process or product. 9

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The importance of cleaning was further emphasized by the publication of the FDA ‘‘Guide to Inspections of Validation of Cleaning Procedures’’ in July 1993. This guide suggests that FDA investigators evaluate key areas including: Availability of approved validation protocols. 2. Approved validation reports. 3. Equipment design and cleanability. 4. Defined, reproducible cleaning procedures that address difficult-to clean areas. Different cleaning procedures are acceptable between batches of the same product and between batches of different products. For manual cleaning operations, it is essential that sufficient detail is provided to give a high level of assurance that the procedure will be performed essentially the same way by different operators. For example, ‘‘wash with water’’ would be totally unacceptable. 10

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5. Time scales between use and cleaning and between cleaning and reuse. 6. Operator training. 7. Specificity and sensitivity of analytical methods—which must be validated, along with recovery levels. 8. Sampling methods: Swab testing of measured areas of surface: The swab is then extracted with an appropriate solvent and the level of extractive quantified. Extrapolation of the amount of residue obtained from the swab to the total surface area of the equipment provides a measure of the total residue—which is potentially capable of being transferred to the next product. advantage of this method is that areas that are hard to clean may be swabbed. disadvantage is that some areas may not be accessible. During the analytical method validation, it is important to demonstrate that components in the swab material do not interfere with the results. 11

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(b) Solvent rinse: After cleaning, the entire equipment surfaces are flushed or rinsed with a solvent in which the materials being evaluated are soluble. By calculating the amount of solvent likely to be left in the equipment, which may later evaporate it is possible to calculate residue levels. This method has the advantage that it can be used for difficult-to-reach equipment parts such as valves and pipe work. It is important to demonstrate that residual materials are not adsorbed onto surfaces thereby giving a low value. (c) Placebo flush: For solid dosage processing it may be possible to flush the equipment system with placebo or excipient material such as lactose. Testing of the placebo for residues of the previous product will provide the required data. This approach is not favored by the FDA, which argues that homogenicity cannot be guaranteed. 12

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(d) Evaluation of next product: In theory this is possibly the most meaningful way to evaluate carryover. However, it does have problems. The analytical methodology to detect traces of product A in product B is complex—especially if every combination of A and B needs to be evaluated and validated. The carryover may not be homogeneous. The method can provide some useful data, but again this is not included in the FDA Guide. (e) Visual examination: should always be performed and there are now ways available to perform this in pipe work. 13


REFERENCE Sidney H. willing, “Good manufacturing practices for pharmaceuticals”, Marcel & Dekker, fifth edition, volume 109, 65-71. 14

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