Aseptic workshop preparation packaging design
Aseptic pharmaceutical cleanroom preparation packaging design
Solid preparations such as tablets and capsules are still the most commonly used dosage forms in sterile workshops. Traditionally, solid preparations are usually packaged in glass or plastic bottles. In order to avoid photolysis, the walls of the container are often amber or opaque, and the container A closed system should have a suitable barrier, while being easy to open and...
Text label: sterile workshop engineering, sterile pharmaceutical cleanroom design and installation, sterile preparation workshop
Aseptic workshop preparation packaging design
Solid preparations such as tablets and capsules are still the most commonly used dosage forms in sterile workshops. Traditionally, solid preparations are usually packaged in glass or plastic bottles. In order to avoid photolysis, the walls of the container are often amber or opaque, and the container The closed system should have a suitable barrier effect while being easy to open and reproducibly close; the bottle opening should be large enough for fast filling and dispensing on high-speed production lines; powders and granules have a variety of uses as final dosage forms, and packaging also Diversified, among which common cold or flu vaccine preparations or granules are dissolved in warm water during use. Such preparations are often packaged in single doses, and one day's dose can be packaged in soft bags for easy portability; sterile powder for injection is Powder is another important application of the final dosage form. During production, the liquid medicine needs to be filled in glass vials or ampoules and freeze-dried. The packaging container should be reasonably designed and optimized to meet the needs of the freeze-drying process and other packaging links.
Traditional liquid preparations are usually packaged in glass containers, but at present a wide variety of materials have low permeability to liquids, and are also widely used in the packaging of liquid preparations. Water-based preparations are the most common liquid preparations, and commonly used packaging materials such as high Density polyethylene is suitable for medium and short-term storage without loss of moisture; many liquid preparations require sterility, and the packaging materials of such preparations need to be able to withstand terminal sterilization. Glass is the best packaging material for sterile liquid preparations, usually Not affected by the sterilization process, it can be made into a variety of specifications and shapes, and it is easy to seal; there are certain limitations in choosing plastic packaging materials, because the interaction between the drug and the packaging material or the performance of the packaging material may occur during the sterilization process. Alterations such as radiation sterilization may generate highly reactive free radicals, and sterilization may also cause other problems if the packaging is not well designed, such as the possibility of peeling of labels from glass bottles during autoclaving. The plastic packaging materials used in injections mainly include polypropylene infusion bags, bottles, multi-layer co-extrusion film bags for infusion, etc. The polypropylene infusion bottle consists of a bottle and a combined cap, and the infusion bag usually contains a bag, an interface and a combined cap. . Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for sterile workshops and GMP workshops.
Semi-solid preparations tend to have high viscosity and poor fluidity. Because they usually contain a lot of water, there are potential problems of product contamination by microorganisms and water loss. Semi-solid preparations include creams, emulsions, gels, ointments and pastes, etc. Packaging should take into account the convenience of preparations; glass or plastic jars or tubes are commonly used packaging containers, such preparations have a large opening area, and appropriate anti-corrosion measures should be taken to avoid microbial contamination; flexible tubes are often used to hold semi-contamination. For solid preparations, the materials of packaging containers are aluminum, polyethylene, and plastic review sheets, and the use of pure aluminum tubes is not common.
Closing and closure systems are an integral part of all basic packaging and must also be economical to aid in protection, presentation and identification and ease of use; the closure itself must be clean and sufficiently inert to prevent It can absorb, adsorb, react or allow external migratory substances to pass through its products and affect the product; the closure can also be used as an integral part of the overall design of the packaging to enhance the attractiveness of the decoration, and the closure can play a functional role in use, such as for Multi-dose packaged preparations need to be attractive; closure can play a functional role in use. For example, for multi-dose packaged preparations, it needs to meet the characteristics of re-closure within the validity period; for products used after reconstitution, closure must undertake two different kinds of inconveniences. Exactly the same effect, i.e. powder or crystalline product before reconstitution and product in liquid form after reconstitution. Common closure systems include bottle caps, hose crimps, rubber stoppers, liners, and heat and adhesive seals.
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