Bulk containers

The application (or Type II DMF) should include a detailed description of the complete container closure system for the bulk drug substance as well as a description of the specific container, closure, all liners, inner seal, and desiccant (if any), and a description of the composition of each component. A reference to the appropriate indirect food additive regulation is typically considered sufficient to establish the safety of the materials of construction. The tests, methods, and criteria for the acceptance and release of each packaging component should be provided. Stability studies to establish a retest period for bulk drug substance in the proposed container closure system should be conducted with fillers or desiccant packs in place (if used). Smaller versions that simulate the actual container closure system may be used. 

Compressed Medical Gases Guideline (February 1989) FDA Guideline for Drug Master Files (September 1989) 

FDA Guidance for Industry on the Submission of Documentation for the Sterilization Process Validation in Applications for Human and Veterinary Drug Products (November 1994) 

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Containers for solids include bags, bulk boxes, cartons, and drums. While the intermediate flexible bulk container (IBC) has become an important package of world commerce, the most used package remains the multiwaU paper bag, supplemented by bags of similar design made of plastic film or plastic woven mesh. 

Bulk Containers These containers may be either open or closed. Generally, it is the effect of the weather on the product that governs the choice. High-value materials, such as certain ores, may be pped in open containers, while relatively low-cost items, such as portland cement, require closed containers. Further influencing the choice of bulk containers is whether dehveries are made by truck, railroad, or water. 

When the bulk containing the binder is uniform, it is compressed on pneumatic, hydraulic, or ram-type presses. Compression can be carried out in presses provided with suitably designed cavities or in metallic pans. The pans ate filled with the powder mass, and a plunger with a cross-sectional shape similar to that of the pan is used to compress the tablet. The resulting tablets ate commonly used with powder puffs or cosmetic bmshes. 

Semibulk Containers. Use of semibulk containers falls between bulk handling, eg, accompHshed by tank cars and hopper cars, and individual package handling, which is often performed manually. Semibulk containers are also known as intermediate bulk containers (IBCs), the provisions and requirements for the constmction and testing of which can be found in the U.N. recommendations (4). 

Land Particulate Bulk Contained Contained Absorbed Adsorbed Contained  

The most important bulk containers are railroad hopper cars, highway hopper trucks, portable bulk bins, van-type (ship) containers, barges, and ships. Factors determining the suit ihty of any of these containers (after establishing whether open or closed containers are to be used) depend on product physical properties, the most important of which are ease of flow, corrosiveness, and sensitivity to contamination. 

TABLE 21-25 Flexible-Type Intermediate Bulk Containers Dimension and Capacity Data (Variable Data)  

Liquids are most economically stored in bulk containers. When large quantities above 25,000 gal must be stored, the tanks should be constructed to the dimensions given by the American Petroleum Institute Standards (see Table 5-2). These tanks must be field-erected. For smaller quantities more economical shop-constructed tanks should be specified. Field fabrication is always more expensive than shop fabrication. A shop-constructed item, in general, must be less than 11.5 ft (3.5 m) in diameter, so that it can be shipped by truck or train. For any piece of equipment that must be shop-fabricated, or for which the cost of field construction is prohibitive, this limitation should be noted. When barges may be used for transportation, this limitation does not hold. 

Static charge generation due to too rapid transfer out of drum or flexible intermediate bulk container (super sack). 

Brush discharges from flexible, intermediate, bulk containers (FIBGs), plastic bags, stretch wrap, or other plastic film 

Use closed equipment wherever possible (hoppers and intermediate bulk containers (IBCs)). 

Fig. 5-17. Principle of micellar-enhanced ultrafiltration (MEUF). The d-enantiomer of a racemic mixture is preferentially bound to the micelles, which are retained by the membrane. The bulk containing the 1-enantiomer is separated through the membrane [72].

Chloroformates are shipped in nonretumable 208-L (55-gal) polyethylene dmms with carbon steel overpacks or high density polyethylene dmms. Eor bulk shipments, insulated stainless-steel tank containers and tmcks provide secure protection. Tank tmck and rail car quantities are shipped using equipment dedicated for these types of products. Materials such as isopropyl chloroformate, benzyl chloroformate, and j -butyl chloroformate that require refrigeration are precooled when shipped in bulk containers. Bulk shipments that are precooled must proceed to the destination without layover. Dmm shipments of IPCE, BCE, and SBCE must be shipped in refrigerated containers. Many of the chloroformates are only shipped in tmck load shipments. The U.S. Department of Transportation (DOT) Hazardous Materials Regulations control the shipments of chloroformates, as described in Table 3. 

To size the amount of space needed for a warehouse, it must be determined how much is to be stored in what size containers. The container sizes that will be used are obtained from the scope. Liquids are generally stored in bulk containers. No more than a week s supply of liquid stored in drums should be planned. Solids, on the other hand, are frequently stored in smaller containers or in a pile on the ground. 

Large quantities of evaporated milk are used to manufacture ice cream, bakery products, and confectionery products (see Bakery processes and LEAVENING agents). When used for manufacturing other foods, evaporated milk is not sterilized, but placed in bulk containers, refrigerated, and used fresh. This product is caHed condensed milk. Skimmed milk may be used as a feedstock to produce evaporated skimmed milk. The moisture content of other Hquid milk products can be reduced by evaporation to produce condensed whey, condensed buttermilk, and concentrated sour milk. 

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