Sterilisation disadvantages

For ophthalmic products, there is a dilemma because recent market trends show that flexible LDPE plastic dropper bottles are popular with users because they offer several advantages, including ease of administration, better control of drop delivery and lower risk of contamination during patient use plastic dropper bottles are lightweight, yet more robust than glass. However, one disadvantage of LDPE containers is that they cannot withstand terminal heat sterilisation using pharmacopoeial recommended heat cycles. 

The use of pressurised steam for decontaminating a freeze-drier The advantages of using pressurised steam as outlined above strictly apply only when sterilising freeze-driers prior to processing parenteral products. When it is intended to use pressurised steam to decontaminate a freeze-drier which has been used to dry hazardous materials, a potentially serious disadvantage should be considered related to the need to raise the... 

The double O ring concept, in particular, is not perceived by many to offer any advantages over the single seal system since it is argued that both seals would be subject to the same conditions of failure and hence the same failure rate. Even if one seal failed, this could probably not be detected in many instances until the planned maintenance and inspection. The prospect of a non-cleanable and possibly non-sterilisable gap between both seals is another disadvantage. 

PLA and PGA polymers, in addition to being susceptible to damage by moisture and radiation, are heat sensitive. Thus, selection of the correct sterilisation technique is of cmcial importance to their physical and mechanical performance in vivo. Table 5.3 gives an overview of the sterilisation techniques commonly used and their advantages and disadvantages. Sterilisation by y-radiation is known to canse chain scission in PLA and PGA polymers. At... 

An ointment base is prepared by melting the ingredients together. Sterilisation can be performed by dry heating (see Sect. 30.5.2) or membrane filtration (see Sect. 30.6.1). Heat sterilisation requires a validated heat steriliser, which may be expensive. In addition, a disadvantage of dry heat sterilisation is the partial decomposition of the fat components. The degradation products could negatively influence the stability of the active substance and probably cause irritation of the eye. 

Plastic bags should be flexible and for most applications sterilisable. PVC can be sterilised at 121 °C. A disadvantage is that PVC is relatively permeable to water vapour. To resist product water loss the bags have to be enclosed in an overwrap that is less permeable to water vapour, for example a laminate material of nylon with polyethylene. 

Sterilisation of aqueous liquids in closed cmitainers by the traditional steam sterilisation process has some advantages and some important disadvantages ... 

Another disadvantage of heat sterilising the fresh brown juice is the formation of Maillard reaction products between amino acids and carbohydrates when they are heated to these temperatures. Maillard reactions products are growth inhibitors and reduce the amount of available amino acids and carbohydrates, again, reducing the value of the brown juice as a universal fermentation media. Furthermore, heat sterilisation significantly adds expenses to the low-price end product. 

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