Manufacturing and packing

Various alternative configurations can be used, and in particular some manufacturers employ non-aseptic form-fill-seal operations which usually produce either in-line cup packs or cartons such as TetraPak or Combibloc packs. 

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The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage, taking account of the instructions and information provided by the manufacturer. 

This procedure defines requirements for monitoring of air quality relative to airborne particulates of injection manufacturing and packing area and delineates the responsibilities for assurance of compliance with this procedure. The room number, activity, and location number defined are hypothetical. Individual companies can apply the SOP as a model to develop their own SOPs. 

Hie normal manufacturing and packing sequences for both aseptic and nonaseptic products are shown in Figure 6.3. 

Non-aseptic manufacture and packing Aseptic manufacture and packing... 

Figure 6.3 Normal manufacturing and packing processes for aseptic and non-aseptic products.

Fritzsching B, Schmidt T. A survey of isomalt as a sugarfree excipient for nutraceuticals. Pharmaceutical Manufacturing and Packing Sourcer 2000(Sept) 70-72. 

Larran JM. Micronisation of Pharmaceutical Powders for Use in Inhalation. Pharmaceutical Manufacturing and Packing Sourcer. Spring 2005. 

Equipment may be sterilized or disinfected by heat, chemical disinfection or a combination of both. Many tanks and reaction vessels are sterilized by steam under pressure, and small pieces of equipment and fittings may be autoclaved, but it is important that the steam has access to all surfaces. Equipment used to manufacture and pack dry powder is often sterilized by dry heat. Chemical disinfectants commonly include sodium hypochlorite and organochlorines at 50-100 ppm free residual chlorine, QACs (0.1-0.2%), 70% (v/v) ethanol in water and 1% (v/v) formaldehyde solution. The... 

The design of the stability study is to establish, based on testing a minimum of three batches of the drug product, a shelf-life and label storage instructions applicable to all future batches of the dosage form manufactured and packed under similar circumstances. The degree of variability of individual batches affects the confidence that a future production batch will remain within specification until the expiration date. 

Note Manufactured and packed under anhydrous conditions. 

Production and Shipment. Estimated adiponitrile production capacities in the U.S. in 1992 were about 625 thousand metric tons and worldwide capacity was in excess of lO metric tons. The DOT/IMO classification for adiponitrile is class 6.1 hazard, UN No. 2205. It requires a POISON label on all containers and is in packing group III. Approved materials of constmction for shipping, storage, and associated transportation equipment are carbon steel and type 316 stainless steel. Either centrifugal or positive displacement pumps may be used. Carbon dioxide or chemical-foam fire extinguishers should be used. There are no specifications for commercial adiponitrile. The typical composition is 99.5 wt % adiponitrile. Impurities that may be present depend on the method of manufacture, and thus, vary depending on the source. 

Friction Materials. Sintered friction materials are classified as metal— nonmetal combinations (49,50). These are best manufactured by the P/M process. Clutch plates, brake bands, brake blocks, and packing compositions are examples of friction materials (see Brake linings and clutch facings). 

Leather and leather products Leather tanning and finishing, manufacture of leather belting and packing Scrap leather, thread, dyes, oils, processing and curing compounds... 

The diameter of packed towers may differ depending upon parameters developed by the packing manufacturers and random packing. Conventional packing will require appro.ximat.ely the same diameter as bubble... 

Once the operating conditions are established for a tower, its diameter and height can be chosen using data available from tray and packing manufacturers. The details of tower diameter selection, tray spacing, and internal design are beyond the scope of this text. 

Based on the requirements of the separation, media of suitable pore size, particle size, and surface properties are selected as well as column dimensions and column material. In some cases a suitable combination of media type and column dimensions may be available as a prepacked column. In most cases, this is a more expensive alternative to preparing the column yourself but will provide a consistent quality as assured by the manufacturing and testing procedures of the vendor. The consistent quality may be critical in obtaining reproducible results and may thus be a cost-effective solution. Also, the fact that smaller particle-sized media are more difficult to pack and require special, and expensive, equipment has resulted in that gel filtration media of small particle size, e.g. smaller than 15 /zm, are predominantly supplied as prepacked columns. 

In 1964 Moore (9) coined the term gel-permeation chromatography in his landmark article. For the first time Moore described GPC and the use of ST-DVB spheres as packings for GPC columns. Three patents were issued to the Dow Chemical Company covering the manufacture and use of GPC gels (10-12). 

Granulate, particle-size material specifically manufactured or produced from basic product off-cuts. Supplied by most manufacturers and used for packing or pouring into irregular-shaped enclosures. 

Many confections are coated in a thin layer of chocolate. The latter is a mixture of chocolate, cocoa butter and other fats, blended to form a suitable coating material. This layer melts at a temperature generally in the range 27-34°C. The manufacturer wishes to coat the confection in a thin, continuous layer, and then harden this layer so that the product can be wrapped and packed with the least delay on the production line. 

A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and, where appropriate, installation of the device... 

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