Information Required from Manufacturer

Important Since the PHE have veiy narrow passages to produce high liquid velocity inside, these can get choked due to suspended solids/impurities in the liquids. Hence, it is a good practice to install on-line cartridge type filters/strainers for the liquids. Example—strainers for ensuring proper cooling water flow for cooling hot oleums in an oleum plant.) 

the pipelines should be so arranged and valves provided that it should be possible to backwash the PHE without dismantling it. 

It is also advisable to install flow meters and thermometers/RTD to measure the performance of the unit. This will help keep a track of the actual heat recovery by the unit. 

It is difficult to get the cooling water heated np to a high temperature very close to the temperature (at which the hot process fluid enters the cooling system) when shell and tube heat exchangers are nsed because about 10-15 °C temperature difference is required for good heat transfer. 

However, when PHEs are nsed it is possible to approach very closely the temperature of hot fluid at inlet because high heat transfer coefficients are possible, and a small temperature difference driving force can be enough. 

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RINGDOC Pharmaceutical Literature Documentation approx. 450,000 1976-present DERWENT PUBLICATIONS LIMITED Covers scientific journal literature on pharmaceuticals. Specifically designed to meet the information requirements of manufacturers. Includes papers from over 750 worldwide journals... 

The manufacture of all investigational medicinal products (including placebo) that are intended for a clinical trial must be authorised and conducted according to Good Manufacturing Practice (GMP). This should be supervised and certified by a Qualified Person . An import authorisation is required for any product from outside the EU, which should also be manufactured to GMP standards. (See Ghapters 11 and 12 for information on GMP, manufacturing authorisations and Qualified Persons.)... 

Eventually shopping lists were finished and sent out for quotations, which came as a pleasant surprise. Prices were well below those shown in the catalogs because of quantities ordered. Since the laboratory had not yet been finished, delivery dates were coordinated with estimated requirement dates. Manufacturers representatives, from whom information on instruments had been requested, were quick to show up. This resulted in many free lunches, but not one representative resorted to what is usually called hard sell . They were all very professional. 

There are OSHA standards designed to protect employees from acute chemical hazards resulting lfom reactive incidents-including fires, explosions, and toxic releases. The Hazard Communication Standard (29 CFR 1910.1200) requires chemical manufacturers to evaluate chemicals produced or handled in their workplace and to communicate the hazards associated with the products they produce via labels and MSDSs. The standard also requires all employers to provide information to employees about the hazardous chemicals to which they could be exposed. The PSM Standard (29 CFR 1910.119) requires employers to prevent or minimize the consequences of catastrophic releases of highly hazardous chemicals, including highly reactive chemicals. 

Apart from manufacturing placebo formulations, the company may need to approach the manufacturer of an already marketed product for clinical trial supplies if their medicine is chosen as a comparator. The precise requirements (such as similar size, colour and no identifying features) can be difficult to meet. Any approach may be met with some hesitation for valid reasons, but equally the reaction may be obstructive, asking for unreasonable access to information. It is customary to provide a copy of the protocol, or at the least an outline of it, with clear indication of the material needed and the timeframe for its supply. 

No information was available in the Toxics Release Inventory database on releases of diazinon to air from manufacturing and processing facilities because these facilities were not required to report releases of this chemical prior to January 1, 1995 (EPA 1995a, 1995b). 

The responsibility for providing information about packaging components rests foremost with the applicant of an NDA, ANDA, or BLA, or with the sponsor of an IND. This information may be provided to the applicant by the manufacturer of a packaging component or material of construction and may be included directly in the application. Any information that a manufacturer does not wish to share with the applicant or sponsor (i.e., because it is considered proprietary) may be placed in a Type III DMF and incorporated into the application by a letter from the manufacturer to the applicant that authorizes reference to the DMF. The letter of authorization should specify the firm to whom authorization is granted, the component or material of construction being described, and where the information or data is located in the file by page number or date of submission. This last item is especially important for files that contain information on multiple components or have several volumes. Information in a Type III DMF is not restricted to data of a proprietary nature. DMF holders may include in their files as much or as little information as they choose. In addition, a manufacturer of a packaging component is not required to maintain a Type III DMF. Without a DMF, there is no procedure for the FDA to review proprietary information except by submission to the application. 

A manufacturer s or vendor s inquiry form is a questionnaire whose completion will give him the information on which to base a specific recommendation of equipment and a price. General information about the process in whieh the proposed equipment is expected to function, amounts and appropriate properties ol the streams involved, and the required performance arc basic. The nature of additional information vanes from case to case foi instance, being different for fillets than for pneumatic conveyors. Individual suppliers have specific inquiry forms. A representative selection is in Appendix C. 

Since 1970, the date, shift, manufacturer and product name have been printed in code on the cartridge of cap-sensitive high expls. The manufacturer keeps records, by that day-shift code, and can tell to whom each batch of material was sold. Distributors also are required to keep records of sale. It is thus possible, from the date-shift code, to compile a list of last legal purchasers of expls from a lot with the same date-shift code. BATF maintains a National Explosives Tracing Center, whose function is to coordinate this activity. A typical trace would start with the recovery of an undetonated bomb. This code would be telephoned to the tracing center which would forward the information to the manufacturer, who would provide a list of consumers or distributors. If expls from that lot were sold to a distributor or distributors, they would be contacted for a list of retail purchasers... 

Authority to make inspections, review and copy documents, and take samples and collect other evidence Ability to enforce requirements and to remove products found in violation of such requirements from the market Substansive manufacturing requirements Accountability of the regulatory authority Inventory of current products and manufacturers System for maintaining or accessing inspection reports, samples and other analytical data, and other firm/product information Mechanisms in place to assure appropriate professional standards and avoidance of conflicts of interest Administration of the regulatory authority... 

Federal, state, and local governments are demanding more and more information from manufacturers not only the size, composition, and properties of waste streams that are generated, but also what chemicals are added to the process to manufacture the final product, and descriptive information on how these chemicals are used within the process. The third major driver for pollution prevention, then, becomes control of the business. When a business does not make any waste or is below a de minimus level, then only a minimum amount of information is required by the governing bodies hence, business information is conserved. Thermodynamic principles govern that zero waste is not possible, and the technical challenge is develop manufacturing processes that produce minimum waste. 

Information obtained from visits to various munitions factories suggests that manufacturers will use whatever is available at the time, from whatever source, to complete an order, provided that it meets the required ballistics performance and produces no residues that are injurious to the gun. During the war years, shortage of material meant many variations in materials used in manufacture. For these reasons it is unwise to make assumptions about ammunition components and composition, even for the same caliber and manufacturer, as they could vary from batch to batch. The differences between ammunition with the same head stamp can be seen in Table 21.3 for Winchester Western in. 38 Special and. 357 Magnum calibers and in Figure 21.2 for. 30 Ml caliber VE 54 FI and VE 2-61 S. 

TSCA places requirement that manufacturers perform various kinds of health and environmental testing, use quality control in their production processes, and notify EPA of information they gain on possible adverse health effects from use of their products. Under TSCA, manufacturing is defined to include importing, and thus all requirements applicable to manufacturers apply to importers as well. Under TSCA, EPA classifies chemical substances as either existing chemicals or new chemicals. Searches of the nonconfidential, public Inventory, are available. 

It is a fact of experience that pressurized apparatus should be fitted with a control and monitoring unit to ensure an appropriate purging procedure and maintain the protective gas flow and pressure differential which guarantee the safe operation of the apparatus. Purely hand-operated purging procedures are susceptible to errors and slips, and a permanently man-operated flow or pressure control for the protective gas is too remote from all basic principles of economic efficiency. Besides, the standards for pressurization contain requirements for safety devices for zone 1 apparatus (EN 50016) and for type px, py and pz-apparatus (IEC 60079-2, see Table 6.7). So, a safety device, or better a control and monitoring unit, is an essential part of a p-apparatus especially for Group I application and for zone 1. It is by no means an imperative that the control unit forms an integral part of the apparatus or has been made by its manufacturer pressurized apparatus without a control unit shall be marked X and the description documents shall contain all necessary information required by the user to ensure conformity with the requirements of the p-standards. 

Protocols are patterns developed by repeating procedures and fixing the identified problems each time that the procedure is followed. Therefore, protocols are dynamic entities that originally can be developed at a laboratory level but must be adjusted in every new step of the seal -up process. When the manufacturing process moves up in scale, the number of people affected by the protocol increases geometrically. Initially, the information can be obtained from library references, personal tests, interpersonal training, and previous laboratory protocols. However, when the production is scaled up, the information required to fine tune the process comes from monitoring the process itself [2],... 

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