Small Volume Parenterals 523 composition of the closures being used is unknown to pharmaceutical formulator, it becomes difficult to evaluate and conduct compatibility and stability studies. Rubber closures prepared from ethylene propylene elastomers produce less extractive, because these contain very less additives. Certain physical tests including product compatibility should be evaluated while selecting rubber closures. The physical tests to be performed are briefly mentioned below, Compression set: When glass vials are sealed with rubber closures, the closures should not deform. That is, the sealing characteristics of the closures need to be evaluated. of natural rubber is the best. Sealing characteris Coring: When a needle is inserted into a closure a small portion or fragment may Separate out from the closure. This is known as coring. Coring rate depends on the type of elastomers, design of the closure, thickness and design of the needlepoint. Puncture resistance: When a needle is used to puncture a rubber stopper pressure is exerted by the closure, This pressure is. called as puncture resistance. Puncture resistance of needles of 23 - 25 gauge (needles of small diameter) is smaller than that of ineedles of 18 22 gauge (needles of greater diameter). Resealability: The ability of closures to reseal the vials so that contamination and leakage do not occur is known as resealability. Tackiness: This refers to ease of handling. During processing the closures should not stick together. When the closures are sterilized by moist heat, the closures usually stick. Moisture vapor transmission: When hygroscopic powders or lyophilized powders are filled in vials or when an inert gas is used to replace air from the filled containers, the closures should not allow to transmit moisture vapor through them. Moisture vapor transmission depends inversely an the thickness of the closures. Hardness: The hardness of rubber is an important property. Durometer is used to measure this hardness. Closures having durometer value, more than 45 are hard. Closures having durometer value within 30-35 are soft, while the closures having durometer value within 35-45 are average. For puncture of the closure high durometer value is necessary. Compatibility with product: Most commen problems associated with the closures are: '* Leaching of closure components into the product, '* The reaction between closure components and product components, ‘© Adsorption of preservative by the closure.