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Who guideline for cleaning validation coupon
Pallet Knife with Wooden Handle. Sampling Systems is ISO registered. Copyright Sampling Systems Ltd. Reproduction of this website or any of its content is forbidden without written consent. He was considered the cleaning validation subject matter expert in most positions held. His expertise includes developing, validating, and monitoring cleaning processes for equipment used to manufacture small molecule, peptide hormone encased, and large molecule pharmaceutical, OTC, and nutritional products.
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He has authored analytical and recovery methods to cleaning validation documents and has successfully defended legacy cleaning validation documents i. Ecolab is the global leader in water, hygiene and energy technologies and services. Every day, we help make the world cleaner, safer and healthier — protecting people and vital resources. American Pharmaceutical Review is the leading review of business and technology for the pharmaceutical industry throughout North America. Surface sampling should define the swab or wipe used, surface location sampled, surface area sampled, material of construction of the surface, number and condition of the swab s or wipe s , sample storage and stability conditions, swab or wipe diluent, and sampling accessories; qualified analysts should perform the testing.
The surface sampling recovery study should also consider, if applicable, the swab or wipe wetting solution and various spiked amounts on the surface. The spiked amount and design of the surface sampling recovery test should challenge the sampling and analytical procedure. The analysis of swab recovery from various active pharmaceutical ingredients as well as cleaning agent residues from a single site using various materials of constructions including metals, plastics, and elastomers supported that stainless steel could be used as a representative surface for swab recovery Forsyth, et.
Visual inspection is important to ensure that the equipment looks sufficiently clean to proceed with analytical testing.
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There are limitations, similar to surface sampling, with routine visual inspections, such as large equipment or lengths of piping, as well as the time and resources required for proper visual inspection. Visual inspection can be defined as the process of using the unaided eye as the sensing mechanism from which judgments can be made about the condition of a unit to be inspected.
A visual non-uniformity on equipment surfaces may present as an interruption of the normal pattern or grain either by residue or discoloration in amount as perceived by the unaided eye. This non-uniformity could be on the surface, such as visible residue, particulate matter, pooling of liquid, or rouge oxides or within the surface, such as scratches, corrosion, or etching. During the design and qualification stages of the lifecycle model, a correlation between visual inspection, surface sampling, and rinse sampling should be performed, so that a visual inspection or rinse sample can be scientifically justified to determine that the equipment, piping, or parts are cleaned.
Visual inspection as the method to assess for cleanliness is ideal for small parts or open process equipment that are easy to inspect. Several published articles have evaluated the use of visual inspection procedures and the role of visible cleanliness in control of critical variables, as well as establishing visible residue limits of select analytes. Forsyth et al.
A large biopharmaceutical manufacturer was designing a new facility for the final compounding and filling of their product. This standard parenteral facility consists of an automated parts washer, steam sterilizer, automated vial washer, depyrogenation tunnel, filling machine, closure machine to insert stoppers, capping machine, and product labeler. This product was being filled by a contract manufacturing organization CMO , which was using only water for cleaning. During the design phase of the cleaning program, coupon testing was performed by coating the finished product onto stainless-steel coupons and evaluating the cleaning with water and a formulated alkaline cleaning agent to remove the finished product.
Water-only cleaning at ambient to 80 oC was not sufficient to yield a visual clean and water-break free surface. In support of a visual inspection program of the items being washed in the parts washer, a visible residue limit VRL study was performed on the final drug product as well as on a formulated alkaline cleaning agent on stainless-steel and glass surfaces. The VRL study procedure consisted of precleaning and drying stainless-steel coupons with a 2B finish as well as borosilicate-glass coupons.
The roughness of the stainless coupons was comparable to the L stainless-steel specifications for the filling parts. The formulated acid and alkaline cleaning agents as well as the finished product were compatible with stainless steel, so the use of these coupons as a test substrate versus L was justified. The test samples were serially diluted, and 1 mcl of diluted sample and 20 mcl of low TOC de-ionized DI water were applied over a 1-cm2 area.
The sample was then allowed to air-dry at ambient temperature for at least 16 hours. After drying, the coupons were inspected by two analysts, in duplicate, at one of the following distances 0.
A light meter Cooke Corporation Cal-Light lux , digital protractor, and 1—5 mcl syringe Hamilton were used in the study. The borosilicate glass surface was used in the construction of the viewing endcap on the final formulation compounding tank, so the higher VRL observed was not critical.
source The visual inspection procedure as well as the inspector qualification study consisted of precleaning and visual inspection of the coupons before spiking. This procedure is used to try to eliminate phantom residues or false positives. The coupons were placed flat on a table in front of a fume hood in groups of three, and the inspector stood back approximately 0.
The lighting in the room was between and lux. Rinse sampling is commonly used to evaluate surface cleanliness of closed production equipment, hoses, and piping commonly cleaned by CIP systems 23— The advantages of rinse sampling are that the entire surface can be sampled, with no disassembly of equipment and no direct sampling of the surface, and that rinse sample analysis via conductivity, TOC, UV, and other methods in-line or on-line can be adapted to PAT technologies.
The disadvantages of rinse sampling are that the analyte measured may not be soluble in the rinse solution, rinsing may not pick up the residue due to poor coverage during rinsing, and the analyte may be too diluted in the rinse solution volume. Rinse recovery studies can be used in addition to assessing the solubility of the active ingredient in the rinse solution. The studies are performed by adding a specified concentration, around the acceptable limit, of the residue on the surface.
The selection of the residue, conditioning of the residue, surface material, roughness of the surface, rinse solution, volume of rinse solution per surface area, rinse solution temperature, and flow rate should all be considered in setting up a rinse solution recovery study. Two rinse recovery studies are discussed as examples.
Figure 6. First rinse recovery study; linearity between conductivity to concentration of a formulated alkaline cleaning agent. Figure 7. Second rinse recovery study; linearity between total organic carbon TOC and concentration of a formulated alkaline cleaning agent. Conductivity and pH results, hour air-dried samples. Total organic carbon TOC results, hour air-dried samples. Three lots of the formulated alkaline cleaning agent were diluted at various concentrations between 1 and ppm by volume using DI water and tested at ambient temperature.
Temperature compensation was not used for this testing. Three lots of the formulated alkaline cleaning agent were diluted at various concentrations between 0. Solution was applied in drops to provide a uniform coverage. Samples were air-dried on the coupons in a horizontal position. After drying, mL of DI water at ambient temperature was poured from a squeeze bottle over the coupon so that the flow cascades down the face of the coupon for approximately 30 seconds.
Surface cleanliness is crucial in ensuring that process residue, cleaning agent residue, and bioburden do not adversely affect the safety, quality, and potency of the drug manufactured. Surface cleanliness can be determined through surface sampling, rinse sampling, and visual inspection. The preferred method is surface sampling through swabbing, wiping, or direct measurement. Surface sampling can add production delays, increased sampling costs, and often increased safety risk to the analyst. If the engineering of the equipment, coverage testing of the equipment, and cleaning agent and analytical method selection have been well vetted during the design and qualification stages of the lifecycle approach, then rinse sampling or visual inspection can be successfully used to demonstrate surface cleanliness.
Attention to detail and application of a risk-based approach during the design stage can provide justification for using either rinse sampling or visual inspection in determining surface cleanliness.