Interim report on heat sterilized fluids for parental administration / Medicines Commission.

  • Great Britain. Medicines Commission.
Date:
1972
Catalogue details

Licence: Open Government Licence

Credit: Interim report on heat sterilized fluids for parental administration / Medicines Commission. Source: Wellcome Collection.

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    (i) (ii) 5.4 (i) (ii) If a plug closure is ill-fitting or if the neck bore of the bottle is misshapen micro-organisms ‘may penetrate the seal between bottle and closure. Any subsequent disturbance of the closure during storage, transport or use may result in microbial contamination of the contents. This hazard is increased with bottles filled under vacuum. Where an overseal is used moisture may collect on top of the rubber closure and become contaminated. When the closure is pierced the contents may become contaminated. The Committee therefore recommend that: Glass bottles should be sealed with tightly fitting rubber plug closures held firmly and securely in place by an aluminium screw cap or retaining ring. The sterilization procedure should ensure that on removal from the autoclave the top surface of the rubber closure is dry and therefore less liable to support the growth of bacteria. 6.1 The Committee considered whether plastic containers had 6.2 (i) (ii) (ili) (iv) (v) (vi) The advantages of plastics Plastic containers are collapsible and do not require an airway, hence there is less risk of contamination. There is no problem from flaking of glass or leaching of particulate matter from rubber closures as there is with glass containers. They are less fragile. They suffer less from closure faults and are not subject to hairline cracks as are glass bottles (see 6.2[vii] and 6.2 [viii] below). Disinfection of the closure.is unnecessary in some cases because of the use of sterile administration ports protected by removable caps. They are lighter in weight, cheaper and easier to transport and less liable to incur damage in transit.