Quality of the Product

The qualities of the product and their tolerances must be deduced from the protocols of the development. The methods to measure the qualities must be described as documented in the development protocols. The directives (a) to (t) are not detailed here. They must be written in accordance with company policies and the Quality Systems Manual for each individual production. The tolerances are given in brackets e. g. 1 °C.  

1 The product to be frozen can be stored and handled at maximum XX °C YY °C for a period of maximum XX hours +YY hours. If the temperature limits and/or time limits are exceeded, directive (a) must be applied. 

3 After cooling the product to minimum -40 °C (+0 °C, -5 °C the product has a uniform, fine structure. This product could be well but slowly dried. To induce some growing of the ice crystals the product must be kept for XX min (-0 min, +YY min at a temperature of e. g. -30 °C (-3 °C, +0 °C. With this tempered structure, rmd = XX hours ( 0.5 h. If fmd is shorter than or exceeds this time, directive (d) is to be applied. 

5 The product temperature during secondary drying must reach T sd +35 °C +0 °C, -4 °C. If Tpr%ti is not measured directly, directive (e) must be applied. 

6 At the end of secondary drying, dW of the product must be 0.6 % ( 0.3 % at +35 °C. If 0.6 % is not achieved, follow directive (f). The residual moisture content (RM) of the product in the closed vials measured by the methods given in directive (g) must be 1 % (standard deviation of all vials measured 0.4 °C or smaller.  

5 Qualification of the installations to document the ability of the equipment to operate the process described in Section 6.2.2. 

6 Documentation of the quality of the manufactured product and its comparison with Section 6.2.1. 

The qualities of the product and their tolerances must be deduced from the protocols 

They must be written in accordance with company policies and the Quality Systems 

Manual for each individual production. The tolerances are given in braces, e.g. 

---

Analytical and control methods for acetic anhydride are fully discussed in reference 55. Performance tests are customarily used where the quality of the product is cmcial, as in food or pharmaceutical products. Typical specifications are ... 

Basic Principles of Operation RO and NF are pressure-driven processes where the solvent is forced through the membrane by pressure, and the undesired coproducts frequently pass through the membrane by diffusion. The major processes are rate processes, and the relative rates of solvent and sohite passage determine the quality of the product. The general consensus is that the solution-diffusion mechanism describes the fundamental mechanism of RO membranes, but a minority disagrees. Fortunately, the equations presented below describe the obseiwed phenomena and predict experimental outcomes regardless of mechanism. 

Shell Gas B.V. has constructed a 1987 mVd (12,500 bbhd) Fischer-Tropsch plant in Malaysia, start-up occurring in 1994. The Shell Middle Distillate Synthesis (SMDS) process, as it is called, uses natural gas as the feedstock to fixed-bed reactors containing cobalt-based cat- yst. The heavy hydrocarbons from the Fischer-Tropsch reactors are converted to distillate fuels by hydrocracking and hydroisomerization. The quality of the products is very high, the diesel fuel having a cetane number in excess of 75. 

Thus the above methods allow to realize a sanitary and chemical control of the quality of the products which have been fortificated by iodine and selenium. 

The higher price of such tea bags is justified by the higher quality of the product. Every pharmacist should be in a position to make clear this essential advantage to his clients. 

Use of freshly distilled bis(silyloxy) compound is critical in many cases, especially in this example. The yield and, more particularly, the quality of the product deteriorate with the age of the sample. Traces of acid should he avoided because even as little as one drop of chloro-trimethylsilane added to the reaction mixture produces a diflferent product. The longer the reaction time in the presence of acid, the greater is the number of other products formed. 

A determination by the method of Pucher, Vickery, and Leavenworth showed that 26 g. of citric acid remained in the sulfuric acid solution. It is inadvisable to use this solution for another run the accumulation of water and by-products reduces considerably the yield and the quality of the product. 

A product which possesses features that satisfy customer needs is a quality product. Likewise, one that possesses features which dissatisfy customers is not a quality product. So the final arbiter on quality is the customer. The customer is the only one who can decide whether the quality of the products and services you supply is satisfactory and you will be conscious of this either by direct feedback or by loss of sales, reduction in market share, and, ultimately, loss of business. 

The requirements of ISO 9001 do not apply solely to one department. As everyone in some way contributes to the quality of the products and services provided by the supplier, everyone shares the responsibility for the quality of these products and services. Every manager within an organization makes a unique contribution towards the organization s purpose and mission. The achievement of quality, however, is everyone s job but only in so far as each person is responsible for the quality of what they do. You cannot hold each person accountable for ensuring that the requirements of ISO 9001 are implemented and maintained, as the requirements apply to the organization as a whole and not to any specific individual. It is a trait of human nature that there has to be a leader for an organization to meet an objective. It does not do it by itself or by collective responsibility - someone has to lead hence the purpose of this requirement. 

In addition to products and service which are incorporated or which form part of the products and service supplied to customers, there are tools, test equipment, contract labor, facilities, calibration services, computer services, and many other items which, if not of adequate quality, may adversely affect the quality of the products and service you supply. These items should also be governed by these requirements. 

The quality of the product or service can be verified by you on receipt using your normal inspection and test techniques. (This is the least costly of methods and usually applies where achievement of the requirements is measurable by examination of the end product.)... 

The quality of the product can be verified by you on receipt providing you acquire additional equipment or facilities. (More costly than the previous method but may be economic if there is high utilization of the equipment.)... 

The quality of the product can be verified by you witnessing the final acceptance tests and inspections on the subcontractor s premises. (If you don t possess the necessary equipment or skill to carry out product verification, this method is an economic compromise and should yield as much confidence in the product as the previous methods. You do, however, need to recognize that your presence on the subcontractor s premises may affect the results. They may omit tests which are problematical or your presence may cause them to be particularly diligent, a stance which may not be maintained when you are not present.)... 

The quality of the product can only be verified by the subcontractor during its design and manufacture. (In such cases you need to rely on what the contractor tells you and to gain sufficient confidence you can impose quality system requirements, require certain design, manufacturing, inspection, and test documents to be submitted to you for approval, and carry out periodic audit and surveillance activities. This method is usually applied for one-off systems or small quantities when the stability of a long production run cannot be achieved to resolve problems.)... 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

Do obtain proposals as to how the subcontractor proposes to control the quality of the product or service before acceptance of tender. 

Whether or not 100% on-time delivery is a requirement of your customers, you won t retain customers for long if you continually fail to meet their delivery requirements, regardless of the quality of the products you supply. It is only in a niche market that you can retain customers with a long waiting list for your products. In competitive markets you need to exceed delivery expectations as well as product quality expectations to retain your market position. 

Bj 23.3 g of 2,6-dihydroxymethylpyrldine-bis(N-methylcarbamate), prepared as described above, are dissolved in a boiling mixture of 46.6 ml of methanol and 46.6 ml of water. When the dissolution is complete, the solution is allowed to cool under slow stirring, without applying any external cooling means. The crystals start to separate at 48°C to 50°C. When the temperature of the mixture falls spontaneously below 35°C, it is cooled externally to 0°C to 5°C, and allowed to stand at this temperature for about 8 hours. Theseparated substance isfiltered off and dried at 50°C to 100°C. 22.65 g of 2,6-dihydroxymethylpyridine-bis(N-methylcarba-mate) are obtained. The quality of the product meets pharmaceutical requirements. 

Ionic liquid synthesis in a commercial context is in many respects quite different from academic ionic liquid preparation. While, in the commercial scenario, labor-intensive steps add significantly to the price of the product (which, next to quality, is another important criterion for the customer), they can easily be justified in academia to obtain a purer material. In a commercial environment, the desire for absolute quality of the product and the need for a reasonable price have to be reconciled. This is not new, of course. If one looks into the very similar business of phase-transfer catalysts or other ionic modifiers (such as commercially available ammonium salts), one rarely finds absolutely pure materials. Sometimes the active ionic compound is only present in about 85 % purity. However, and this is a crucial point, the product is well specified, the nature of the impurities is known, and the quality of the material is absolutely reproducible from batch to batch. 

The management of production is well described by Hill, but the prime consideration is product flow, and all features of the layout must assist flow. There are some indicators which can be used to measure the quality of the production facilities, and these can be employed to demonstrate the viability of the proposed new layout. 

The primary indicator of acceptable performance is the quality of the product delivered by the mixer. Although there is no direct way to measure this indicator, feedback from the quality assurance group should be used to verify that acceptable performance levels are attained. 

If the quality of the product is not so critical or if further purification steps are planned, hydrofluoride synthesis can be performed using a regular black steel container. 

The defluorination of the complex acids is a key step in the production of tantalum and niobium oxides as it defines the quality of the products and durability of the production equipment. 

Application of an excessive amount of ammonia solution in the precipitation of tantalum and niobium hydroxides from strip solutions usually ensures good quality of the products. Nevertheless, the method has two general problems. First, hydroxides containing low levels of fluorine contamination... 

Additional purification of the product and improvement of particle size and shape can be achieved by re-ciystallization. The process consists of sequential dissolutions of potassium heptafluorotantalate in appropriate solutions at increased temperatures, filtration of the solution to separate possible insoluble parts of the product and cooling of the filtrated solution at a certain rate. The precipitated crystals are filtrated, washed and dried to obtain the final product. Re-crystallization can be performed both after filtration of the preliminary precipitated salt or after drying if the quality of the product is not sufficient. HF solutions of low concentrations are usually used for re-ciystallization. In general, even water can be used as a solvent if the process is performed fast enough. Nevertheless, practical experience suggested the use of a 30—40% HF solution within the temperature interval of 80-25°C, and a cooling rate of about 8-10°C per hour. The above conditions enable to achieve an acceptable process yield and good performance of the product. 

The product designer should caution the tool designer to keep the gate area away from load-bearing surfaces and to make the gate size such that it will improve the quality of the product. It so happens that the product wall in the gate area develops the minimum tolerance due to the high melt pressure in that area. 

A practical method of prepg this compn was by the addition of a soln of the coating agent to an aq RDX slurry. Based on the quality of the product and the pellet densities obtained, a procedure of adding an acet soln of PVA + DBP to a hot w slurry of RDX, under agitation, was adopted as standard... 

The basic electrorefining process is now being used on a production scale for the purification of non-specification plutonium metal. The technology is sufficiently well developed to permit 24-hour unattended operation of the electrorefining cells, and the quality of the product metal is highly consistent. This technology is rapidly replacing aqueous chemistry for plutonium metal purification. 

The main process variables which have a significant effect on the quality of the product are ... 

The quality of the product must meet high requirements of USP XXII and FDA regulations, considering high pharmacological activity of any present impurities. Therefore, the investigation of impurities and degradation products has absolutely been necessary. 

Dichlorodibenzo-p-dioxin was prepared from isotopic potassium 2,4-dichlorophenate uniformly labeled with Ullman conditions gave a 20.5% yield. Small amounts of dichlorophenoxy chlorophenol were removed from the product by extraction with sodium hydroxide before purification by fractional sublimation and recrystallization from anisole. Chlorination of 2,7-dichlorodibenzo-p-dioxin in chloroform solution containing trace amounts of FeCls and 12 yielded a mixture of tri-, tetra-, and pentachloro substitution products. Purification by digestion in boiling chloroform, fractional sublimation, and recrystallization from anisole was effective in refining this product to 92% 2,3,7,8-tetrachloro isomer, which also contained 7% of the tri- and 1% of the penta-substituted dibenzo-p-dioxin. Mass spectroscopy was used exclusively to monitor the quality of the products during the synthesis. 

---