Supplier Readiness

The readiness of the various SMPR suppliers must be assessed in a number of ways. In this report the following has been excerpted from each supplier s answer to indicate how ready each would be to enter a competitive bidding process  

1 Site preparation and evcavation. base-mat pout irsg 

The readiness of the various SMPR designs currently offered or proposed by the nuclear suppliers, and their respective design and availability schedules are given in the Annex I to the report. A final definition of readiness, however, would only be achieved when a bid is requested. 

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There are obvious benefits to be derived from consensus standards which define the chemistry and properties of specific materials. Such standards allow designers and users of materi s to work with confidence that the materials supplied will have the expected minimum properties. Designers and users can also be confident that comparable materials can be purchased from several suppliers. Producers are confident that materials produced to an accepted standard will find a ready market and therefore can be produced efficiently in large factories. 

The suppliers typically offer coater-ready adhesives thus leaving little freedom for formulation and performance adjustment by the end user. However, they have also developed a significant knowledge basis, which has allowed them to make silicones into a very versatile, yet specialized class of PSAs. 

In the majority of cases common sense, combined with basic engineering principles, should be sufficient to ensure good service from the tower on a continuous basis. The reputable supplier will always be ready to help and advise. If the advice is sought in time, many of the problems associated with the changes mentioned need never arise. 

Unless a thermostatic expansion valve is very tightly rated, the system will operate satisfactorily at a lower condensing condition in cool weather, with a gain in compressor duty and lower power input. A growing awareness of energy economy is leading to more careful application of this component. Suppliers are ready to help with advice and optimum selections. 

Some gum users now take gum in a pre-prepared form. Spray dried gum acacia has been used in pharmaceutical products for some time. The spray dried gum offers the pharmaceutical manufacturer a clean ready to use product. Instant forms of gum acacia have been offered by suppliers for some time. The instant products can be rapidly made into solution and used. Obviously the instant gum is more expensive. A manufacturer that uses gum as a minor ingredient may well find that the capital and labour cost of purifying raw gum is not cost effective. A company that uses gum acacia as a major ingredient might come to a different conclusion. Instantised gums pose different problems to the analytical chemist.. One approach that can be used is to have an optical rotation specification for the product. Even this approach is not entirely proof against a material that contains a blend of gums of different optical rotation. 

Market and actors In Germany approximately 32 m. tons of cement are manufactured, of which about 16% are processed manually, 31% are used in factory manufacture of concrete parts and 53% are used in the manufacture of ready-mixed concrete. Around 5.5 m. tons are imported. The cement industry operates in a Fordist stmctured market for mass products (lengthy product cycles, dominated by price competition) with trends towards monopolies. Raw materials suppliers and downstream businesses (e.g. cement transportation enterprises) are also being controlled increasingly by the cement manufacturers. 

An alternative approach for alleviating these logistical issues, that may be amendable to some assay, is to use assay-ready frozen stocks. Cells frozen at high concentration would be seeded into assay plates and used later that day or the next. The build-up of frozen stock reserves is then independent of current demand and can even be purchased directly from suppliers. At least one such supplier has taken a step further by also providing ready-to-use assay plates with cells frozen within. By simply adding media it is possible to revitalize the cells and run your assay within hours [2]. 

The handbook provides ready information on the fire and chemical reactivity of commonly used chemicals. Its purpose is to provide basic information important to the safe handling of chemicals and to help provide guidance in responding to a hazardous materials incident, in particular, incidents involving reactive chemicals and materials posing fire and explosion hazards. The data and information on each chemical have been compiled from several sources, including the CHRIS data base, material safety data sheets from chemical manufacturers and suppliers, and various references cited at the end of this first chapter. This first chapter provides an explanation of the terms used in chemical specific discussions and also provides basic guidance on how to extract information from the handbook. 

The guiding principle of the founding team is reflected in the company motto "ChemKit - Ready for a revolution" bringing together users and suppliers of chemicals with a revolutionary, service-oriented business model. 

The commercial suppliers of ion exchangers provide detailed instructions for the preparation of the adsorbents. Failure to pretreat ion exchangers will greatly reduce the capacity and resolution of a column. Most new ion-exchange resins are commercially available in slurry form and are ready to use with a minimum number of pretreatment steps. 

In many instances operating system software has already been developed and is offered as a fundamental part of the computer system ready for application software to be developed or configured. In such cases it is prudent to establish the existence of the respective software quality assurance plans and procedures and the design, development, and testing records. Identification and examination of this documentation can be conducted and recorded as part of the supplier audit. (See Sec. VI.)... 

Polyethylene glycol 4000 MW is normally used for cell fusions. Batches may vary in their ability to produce viable hybridomas and it is wise to test a few batches from different sources prior to undertaking hybridoma project work. A number of biochemical suppliers now produce ready-to-use PEG/media solutions in sterile ampoules, which workers may find is a more practical source. 

Many commercial suppliers (Table 10.3) have established protocols and procedures that address many of these issues. Primary human and animal cells of a variety of types are often available, sometimes as ready-to-use frozen stock aliquots or already added to 96-or 384-well plates. Specific culturing medium and detailed protocols for the correct maintenance of the cell line in culture are usually provided as well. This should facilitate the use of primary cells for primary HTS and compound validation. 

Presently, the most promising raw material for commercial production of chitinase (in terms of cost per unit activity and ready availability to satisfy present and future demand) is soybean seeds. Table I shows a comparison of cost (based on the retail prices) for the production of chitinase from microbial sources by three commercial suppliers and from soybean seeds. The cost is very high for the commercially prepared enzyme. The method used to purify the soybean enzyme (33) has an average yield of 3.6 I.U./kg or 3600 I.U./metric ton soyEean seeds. The cost for producing 3600 I.U. chitinase from the three suppliers has been calculated and shown in Table I. The Sigma ana Calbiochem-Behring preparations contained the lowest specific activities. 

It is increasingly common for components to be supplied by the vendor in a ready-to-sterilize condition (washed and pretreated as necessary). Some items are available in a ready-to-use configuration with the supplier providing sterile and pyrogen-free components. The use of supplier-prepared items eliminates the need for preparation activities at the fill site and requires modification of material in-feed practices relative to on-site prepared items. 

REPKesentafciyg tat Sawles and Analyses- Suppliers of catalyst and fixed bed adsorbent are being requested to supply representative lot samples and analytical certificates for each nev purchase order at the time the catalyst is ready for shipment. The analytical results are being compared with updated purchase specifications. 

An inventory of systems and knowledge, of which one is GMP-critical, must be maintained and available for inspections. An MHRA preinspection checklist has this as one of its opening topics. The availability or otherwise of this information is a clear indicator of whether management is in control of its computer systems validation. The use of an inventory need not be limited to inspection readiness it could also be used for determining supplier audits and periodic reviews, etc. Many pharmaceutical and healthcare companies use a spreadsheet or database to maintain this data. Where a site s inventory is managed between a number of such applications (perhaps one per laboratory, one for process control systems, one for IT systems), care must be taken that duplicate entries are avoided and, equally, that some systems are missed and not listed anywhere. It should be borne in mind that where spreadsheets and databases are used to manage an inventory, it should be validated just like any other GxP computer application. 

Data migration from one platform and environment to another was accomplished using the utilities supplied by the supplier. For most eases the tools were successful, however the inability to migrate the previously fitted baselines is a major flaw that prevents the ready replay of data. If data are auto-processed, equivalent results are obtained. A key for success is the teehnieal imderstanding of both environments so that parameters can be mapped between the two. 

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