Finished product controls

Process controls include daily testing of water for injection (USP), conformation of fill doses and yields, checking and approving intermediate production tickets, and checking label identity and count. Finished product control includes all the tests necessary to ensure the potency, purity, and identity of the product. Parenteral products require additional tests, which include those for sterility, pyrogens, clarity, and particulate analysis, and for glass-sealed ampoules, leaker testing. 

Very widespread for precise routine and non-routine analysis in industrial and research laboratories. Typical uses determination of acidic and basic impurities in finished products, control of reaction conditions in industrial processes, mineral and metallurgical analysis. Relative precision 0.1-1%. 

Intermediate Product Control Tests Finished Product Control Tests... 

Within a company, QC action is directed at three areas raw material control, process control, and finished product control. The approach in setting up a system will be very similar in each case, i.e. design into the operation all the parameters that will bear on the manufacture of quality, followed by a means of establishing that conformance has been achieved. (An important element of this is the continuing revalidation that processes continue to perform as specified.)... 

In the modem organisation it is difficult to separate production-operated SPC from QC-operated finished product controls. They must complement one another within the following broad definitions. 

Finished product control QC procedures, separate from production operations, to ensure that released product complies with agreed standards (which can be company-based or nationally/intemationally imposed specifications). 

Before development of modem QA principles and QC technology, finished product control was the main (and perhaps only) preoccupation of the QC department. Finished products were often sampled at the end of the process and, after inspection, classed as acceptable or not acceptable. Following this decision, it was expected that the surprise news of a quality problem would be investigated and remedial action introduced. 

The finished product control will be based on the finished product specification and will detail the tests, sample size and frequency necessary to ensure compliance. As with the inspection of bought-in components, testing procedures will include details extracted from national and international standards (pharmacopoeias, military standards, etc.). They will however have one major advantage over systems designed to vet bought-in materials, i.e. the higher confidence synonymous with in-house manufacture. 

As with in-process production checking, finished product control can employ statistical techniques and control charts or can be derived from national sampling procedures such as MIL-STD 414 (sampling, procedures and tables for inspection by variables for per cent defectives). These sampling procedures are very similar to and complement the sampling, procedures and tables for inspection by attributes (e.g. MIL-STD 105E) and can be used in a similar manner. 

The finished product control will be a standard procedure covering primary and secondary pack characteristics such as the following. 

The purpose of the nondestructive control consists in detecting local modifications of the material parameters which, by their presence can endanger the quality of the half-finished or finished products. The electromagnetic nondestructive control permits to render evident surface and subsurface discontinuities in the electroconductive material under test. The present tendency of this control is to pass from a qualitative evaluation (the presence or absence of the material discontinuities which give at the output of the control equipment a signal higher or at least equal to that coming from a standard discontinuity whose shape and severity has been prescribed by the product standards) to a quantitative one, which enables to locate as exactly as possible the discontinuity and to make predictions over its shape and severity. 

Manufacturing processes have been improved by use of on-line computer control and statistical process control leading to more uniform final products. Production methods now include inverse (water-in-oil) suspension polymerization, inverse emulsion polymerization, and continuous aqueous solution polymerization on moving belts. Conventional azo, peroxy, redox, and gamma-ray initiators are used in batch and continuous processes. Recent patents describe processes for preparing transparent and stable microlatexes by inverse microemulsion polymerization. New methods have also been described for reducing residual acrylamide monomer in finished products. 

Cotton linters or wood pulp are nitrated using mixed acid followed by treatment with hot acidified water, pulping, neutralization, and washing. The finished product is blended for uniformity to a required nitrogen content. The controlling factors in the nitration process are the rates of diffusion of the acid into the fibers and of water out of the fibers, the composition of mixed acid, and the temperature (see Cellulose esters, inorganic esters). 

Test salons are often used to evaluate hair fixatives. Half-head studies are performed, with the test product appHed to one side of the head and a control product to the other in reaHstic use amounts. Similar properties as desctibed in laboratory tests are measured. Finished products are often sent to testers homes where they have an opportunity to evaluate the products in real use situations for extended pedods. 

QuaHty control in the production of organic solvent finish removers may be done by gas—Hquid chromatography, which allows the manufacturer to determine the actual ratio of volatile solvent present in the finished product. If the product does not meet specifications, solvents can be added to bring the product to an acceptable composition. A less expensive approach is to use a hydrometer to determine the specific gravity of the product. The specific gravity indicates if the proper blend has been reached. Nonaqueous acid—base titration may be used to determine the amount of acid or alkaline activator present in a remover. 

A.dditives. Additives control coating behavior during appHcation or they can be used to alter the properties of the finished product. A single chemical additive may be used for several purposes. Some additives are essential to the production of a salable product, and others may be added only to obviate problems of the coating operation. 

Quahty control iaspection is a post-, or at best concurrent, manufacture activity. The QC laboratory reports on ia-process and finished product quahty based on testing. Thus QC confirms whether a material has been manufactured in conformance. Sometimes QC also assists the production unit in salvaging process material or reworking off-standard finished product. 

A wide variety of particle size measurement methods have evolved to meet the almost endless variabiUty of iadustrial needs. For iastance, distinct technologies are requited if in situ analysis is requited, as opposed to sampling and performing the measurement at a later time and/or in a different location. In certain cases, it is necessary to perform the measurement in real time, such as in an on-line appHcation when size information is used for process control (qv), and in other cases, analysis following the completion of the finished product is satisfactory. Some methods rapidly count and measure particles individually other methods measure numerous particles simultaneously. Some methods have been developed or adapted to measure the size distribution of dry or airborne particles, or particles dispersed inhquids. 

Special additives are often included in a carrier formulation to provide specific properties such as foam control, stabiUty, and fiber lubrication during dyeing. Most important are the solvents used to solubilize the soHd carrier-active chemicals. These often contribute to the general carrier activity of the finished product. For example, chlorinated benzenes and aromatic esters are good solvents for biphenyls and phenylphenols. Flammable compounds (flash point below 60°C) should be avoided. 

Raw-materials, intermediate, and finished-product inventories Cost of handling and transportation of materials to and from stores Cost of inventory control, warehouse, associated insurance, security arrangements, etc. 

Describe in detail the controlling characteristics of the finished product ... 

A wet-process plant maldug cement from shale and hmestoue has been described by Bergstrom [Roc/c Prod., 64—71 (June 1967)]. There are separate facilities for grinding each type of stone. The ball mill operates in closed circuit with a battery of Dutch State Mines screens. Material passing the screens is 85 percent minus 200 mesh. The entire process is extensively instrumented and controlled by computer. Automatic devices sample crushed rock, slurries, and finished product for chemical analysis by X-rav fluorescence. Mill circuit feed rates and water additions are governed by conventional controllers. 

Invoices statement of procedure for submitting invoices Quality Control explanation of responsibilities for analysis of supplied materials, finished product, and work in progress consequences of off-spec materials procedure for rework Process Ownership specification of who owns the process, degree of liability for remediation, procedure for review and approval of process changes... 

During the manufacture of glass, considerable dust, with particles averaging about 300 /xm in size, will be emitted. Some dusts may also be emitted from the handling of the raw materials involved. Control of this dust to prevent a nuisance problem outside the plant is a necessity. When glass is blown or formed into the finished product, smoke and gases can be released from the contact of the molten glass with lubricated molds. These emissions are quite dense but of a relatively short duration. 

The most widely used pulping process is the kraft process, as shown in Fig. 6-11, which results in recovery and regeneration of the chemicals. This occurs in the recovery furnace, which operates with both oxidizing and reducing zones. Emissions from such recovery furnaces include particulate matter, very odorous reduced sulfur compounds, and oxides of sulfur. If extensive and expensive control is not exercised over the kraft pulp process, the odors and aerosol emissions will affect a wide area. Odor complaints have been reported over 100 km away from these plants. A properly controlled and operated kraft plant will handle huge amounts of material and produce millions of kilograms of finished products per day, with little or no complaint regarding odor or particulate emissions. 

Nonferrous metallurgy is as varied as the ores and finished products. Almost every thermal, chemical, and physical process known to engineers is in use. The general classification scheme that follows gives an understanding of the emissions and control systems aluminum (primary and secondary), beryllium, copper (primary and secondary), lead (primary and secondary), mercury, zinc, alloys of nonferrous metals (primary and secondary), and other nonferrous metals. 

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