Many innovative biotech drugs are packaged as injections in pre-filled syringes which contain the correct concentrations and amounts. Due to their molecular structure, it is essential that protein medicines are administered parenterally. Based on experience, many producers and users know that particularly with pre-filled syringes the medication comes into contact with more materials than is the case with other types of packaging. Not only that, compared to powder or solid ingredients there is a higher probability that liquid medicines will interact with materials in the primary packaging As a general rule, liquid preparations are more likely to leach dubious substances out of the primary packaging than is the case with powder or tablets.
Eprex is a case in point which illustrates the serious consequences of this type of interaction. The medication had to be taken off the market for a time in 2001. Analysis showed that the polysorbate-80 used by the manufacturer as a stabilizer leached organic compounds out of the uncoated rubber stoppers during storage. This resulted in precipitation and formation of micelles which in some cases led to serious immunological reactions in patients.
Intelligent Design and New Dosage Forms
Active ingredients in syringes come into contact with all of the parts made of glass, plastic, metal and adhesive as well as the silicon oil lubricant. Schott has introduced a new design which reduces possible interaction between the active ingredient and the primary packaging. The intention is to provide a level of safety for sensitive active ingredients similar to that of pharmaceutical vials. The channel which connects the hub and the needle in the new syringes is made of flexible plastic. A seal keeps the liquid passageway closed during storage. The medication cannot come into contact with the metal needle or the adhesive in the syringe during shipment and storage. For added quality, tamper-proofing makes it immediately obvious whether the syringe is new or has already been used.
Developers show almost limitless creativity. A subsidiary of Harro Höfliger has developed a straw for children and the elderly which can be used to administer the active ingredient in pellet form. Patients can ingest the medication along with their favorite beverage. Exact dosing and a control filter ensure that the correct dose is taken.
Process Integration and Flexibility Right Through to Filling
Packaging is by no means excluded from the major trends in the process industry. The strategy is to supply solutions rather than products. Manufacturers must offer a broad range of technologies covering as much of the value-add chain as possible.
A number of acquisitions and partnerships in recent months reveal the tendency to offer one-stop shopping. Romaco acquired Innojet Herbert Hüttlin in order to be able to provide engineering solutions for the entire production and packaging process of pharmaceutical solids. In December 2014, Bosch Packaging announced the formation of a joint venture with Klenzaids to supply complete lines, particularly for the Indian market. Bosch Packaging supplies process water treatment, fermentation, filling, packaging and quality control systems from a single source. Klenzaid specializes in cleanroom and process technology.
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