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Manufacturing parenteral formulations
Fragile molecules such as protein formulations would be destroyed using the alimentary canal and are therefore administered by injection. When making injectable formulations the drugs are stored in liquid or, if unstable at higher temperatures, lyophilized form. To ensure a stable active medium during storage and make the preparation isotonic with blood, liquid formulations combine active ingredients with a minimum amount of excipients such as solvents, solubilizers, suspending, and buffering agents, and antimicrobial preservatives.
Water for injections(WFI) is used as the vehicle for aqueous injections. For non-aqueous injections, fixed oils of vegetable origin are used as vehicles. Water for Injection is used in the preparation of medicines as a vehicle and sterilized water for injection is used when solving or diluting substances or preparations before use. WFI is obtained by distillation or reverse osmosis and meets all chemical requirements for PW (Purified Water) with an additional bacterial endotoxin parameter.
Lyophilized drugs allow storage at higher temperatures after freeze-drying is used to remove water from a liquid drug and create a solid powder or cake. In protein formulations, stabilizers are added to replace the water and preserve the molecule structure. Before administration, a lyophilized drug is reconstituted by combining a liquid diluent with the freeze-dried powder and mixing before injected into the body.
Vaccine development and production technology
Applikon Biotechnology is specialized in human vaccine production systems, as well as in systems for the production of therapeutic agents using both cell culture and microbial cultures.
Their advanced bioreactor systems can be used from the initial screening stage up to full-scale production using the same platform to minimize scale-up risks and guarantee a short time to market in product development.
Visual and high voltage leak detection (HVLD) inspection
Inspection of sealed glass vessels for contaminants, correct fill volume, sealing, and for example tip-cap effects or black spot particles. How convenient to cover all quality inspection requirements at once?
CMP Pharma’s NIKE-LT’s recirculation feature allows re-inspection following rejection by only one or two cameras (user selectable) which brings false rejection rates down reducing unnecessary wastage.
Sterile filling and packing of injectables
Sterile dosage forms must be free from any microorganisms, dust, fibers, and foreign particles, and should be isotonic. Although standards and legislation may differ worldwide there are several regulations to ensure the product or safe and effective new and generic drugs on the market such as USP/JP/EP standards and Current Good Manufacturing Processes (GMP) compliance.
Small-volume parenteral solutions (SVPs) are injections provided in containers 100 ml or less and can be designed for single and for multiple uses. A large volume parenteral (LVP) is a single-use unit dose container of greater than 100ml designed to carry fluids, calories, and electrolytes.
For light-sensitive substances, colored glass containers such as vials or ampoules are used. If possible containers are made transparent for easier visual inspection. Containers are made, as far as possible, from material that is sufficiently transparent to permit visual inspection. Closures are equipped with a firm seal to prevent the entry of microorganisms and other contaminants while permitting the withdrawal of a part of the whole of the contents without removal of the closure. Closures for multidose containers are sufficiently elastic to allow the puncture to reseal when the needle is withdrawn.