Semisolid products packaging

The following changes in the container closure system of nonsterile semisolid products, as long as the new package provides the same or better protective properties and any new primary packaging component materials have been used in and been in contact with CDER-approved semisolid products ... 

Forcinio, H. (1998), Tubes The ideal packaging for semisolid products, Pharm. Tech., 22, 32-36. 

Enhanced turn-over package Installation qualification protocols Operational qualification protocols Change control initiation Cycle development Performance qualification protocol Process validation protocols Validation final reports Validation package Certificate for use in manufacturing Required protocols and procedures for dry production Required protocols and procedures for liquid and semisolid products... 

These are areas where personnel could come into direct contact with open materials (starting materials, intermediate product, bulk product, and open primary packaging materials), for example, all operations (sampling, compounding, and producing) for manufacturing of solids, semisolids, and liquids for oral and topical use. 

For liquid (e.g., solution, suspension, elixir) and semisolid (e.g., creams, ointments) dosage forms, a change to or in polymeric materials (e.g., plastic, rubber) of primary packaging components, when the composition of the component as changed has never been used in a CDER-approved product of the same dosage form and same route of administration. For example, a polymeric material that has been used in a CDER-approved topical ointment would not be considered CDER-ap-proved for use with an ophthalmic oinhnent. 

APV (1981) International Association for Pharmaceutical Technology Praxis der Validierung (Validation in Practice), Symposium (1981-1982, Gelsenkirchen) [6] Terminology, sterile, semisolid, and solid dosage forms in development and production, analytical methods and stability evaluation, packaging development and packaging validation transfer, cost-effectiveness... 

Packaging An ideal container should protect the product from the external atmosphere such as heat, humidity, and particulates, be nonreactive with the product components, and be easy to use, light in weight, and economic [14]. As tubes made of aluminum and plastic meet most of these qualities, they are extensively used for packaging semisolids. Aluminum tubes with special internal epoxy coatings are commercially available for improving the compatibility and stability of products. Various modified plastic materials are used for making ointment tubes. Tubes made... 

Dry or powdered products are packaged in multiwalled paper bags or fiber drums. The bags usually contain 25 kg (50 lb) while drum capacities range from 45 kg to 90 kg (100-200 lb). As is recommended for semisolid plastic products, the storage area for these shortenings should also be cool, dry, and free of... 

Piston Type Since it is difficult to empty the contents of a semisolid from an aerosol container completely, a piston-type aerosol system has been developed. This system utilizes a polyethylene piston fitted into an aluminum container. The concentrate is placed into the upper portion of the container. The pressure from nitrogen 621-690 kPa ( 90-lOOpsig), or a liquefied gas, pushes against the other side of the piston and, when the valve is opened, the product is dispensed. The piston scrapes against the sides of the container and dispenses most of the product concentrate. The piston-type aerosol system is shown in Fig. 19.5. This sytem has been used successfully to package cheese spreads, cake decorating icings, and ointments. Since the products that use this system are semisolid and viscous, they are dispensed as a lazy stream rather than as a foam or spray. This system is limited to viscous materials since limpid liquids, such as water or alcohol, will pass between the wall of the container and the piston. 

Topical aerosols and nasal sprays rely on pump systems to deliver the API in the form of finely dispersed mist or as coarse spray or stream of semisolid. Because of their design, aerosol and nasal products are usually under very high pressure, and this makes it difficult to obtain suitable samples for analysis. In spite of that, a number of very specialized tests which include pressure test, minimum fill, number of discharges per container defivered dose uniformity, delivery rate, leak test, spray pattern and plume geometry test, assay, and microbial enumeration test (MET) have been devised to test the integrity of the aerosol package and the device used to defiver the dose. ... 

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