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Capping Technology: Flaws & Improvements
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Capping Technology - Past Limitations, Process Results, and Problems Currently, ‘capping’ technology involves several methods of mechanically forming the seal on a vial/bottle. For example, several methods use blades to reshape the edge of the cap up under the top of the vial/bottle to form the seal. Such technology has several limitations. · First, the current technology limits the ability to relocate the capping operation into the aseptic space AND maintain the aseptic classification due to particle contamination generated by the current metal forming methods. · Second, the seal is not commonly accepted as a ‘good’ seal – though we recognize that testing the ability to turn a seal versus the vial is not an accurate seal quality test, it is nonetheless widely used. · Third, because of the style of technology used, either the vial/bottle or the ‘head’ on the machine must rotate – this often causes scratching, marring, or even breaking of the container. Some breakage of the container may not be apparent to post-process inspections; glass that may have chipped inside the vial can be extremely harmful to the patient. Another form of breakage, such as a hairline crack, may cause harm to the patient as well. For example, if a hairline crack allows outside atmosphere to interact with medicines that are oxygen sensitive, the medicine may be inactivated or even harmful when given to the patient. · Fourth, in addition to possibly harmful effects of damaging the container, current technology creates cosmetic side-effects that internal and external quality departments, clinicians, and physicians often reject. For example, a vial that may have perfectly good product inside it, but a cap that has been partially sliced by the aforementioned blade, may often be required to be rejected by doctor, thereby losing that dosage and increasing the cost of medicines. Therefore, there is a need in the industry for a technology, specifically a machine that can continuously, securely cap vials and bottles, and do so without: · Generating particulates, in order to be relocated into the Aseptic space and meet FDA (U.S. Food and Drug Administration) and EMEA (European Regulatory body) requirements · Damaging the container, be it thru cracks, chips, scratches, etc. |
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