The specified limits of 5% to 95% RH are pretty broad; however, with a pouch like yours that has a high MVTR, continuous exposure to an atmosphere outside this range would clearly lead to the interior of the pouch also being outside the limits eventually.
The low-level RH limit is likely to be encountered in winter within heated buildings in cold areas such as Finland. Cold dry outdoor air falls to extremely low RH when heated to a comfortable temperature for humans; this low RH has been known to result in brittle fracture of nylon bone straps. Recently in Ireland, we have had 100% RH outdoors (and indoors as air conditioning in our homes is rare); it must be a common situation in the tropics.
Personally, I have never attempted to measure the humidity within a package but have been concerned of its impact on the moisture content of the product contained. The approach is to weigh unpackaged product taken from the packaging area, condition the same product at the specified humidity limits in a humidity cabinet and compare the new weight with the original; this enables determination of the acceptable range of moisture content.
Sample-filled packages can then be weighed as packaged, stored at worst case low and high RH and weighed at daily intervals until weight change ceases. Separate samples are used for the high- and low-limit test because of the potential hysteresis effect.
ASTM D4332 – 01 (2006), Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing contains helpful guidance for proper package conditioning.
In the past I have found that the Rapid Regain Dryer (as used for wool moisture testing) is a useful tool for use in determining product moisture content.
The UK Packaging Society (formerly the Institute of Packaging) runs a range of courses covering packaging topics including pharmaceutical packaging; however it does not run a medical device packaging course. In the United States, the Institute of Packaging Professionals runs a short course titled “Fundamentals of Packaging Technology”. Conferences and Seminars can be a good source of general medical packaging information. UBM Canon run a series of medical device and packaging trade shows and seminars, all of which can be a source of helpful information.
Some of us honed our packaging skills by reading the trade journals and gaining hands on experience, others spent a few years in college before practising their art. It does mean that to gain an in depth knowledge of medical device packaging takes time. It may be appropriate for you to have a short course tailored to deal with the specific needs of your company, your products and your resources.
The only standard test method that I see referenced in supplier data sheets and medical device manufacturer specifications is ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials. You will find that F88 gives options for peel angle and guidance for reporting results. Your internal procedures should ensure that exactly the same procedure is followed for your tests where the results are to be compared.
The answer is dependent upon many factors. The most important is that no change that might negatively impact the package performance should happen without validation review. Examples of such changes are introduction of a new component manufacturer, change of polymer, introduction of a new thermoforming machine, overhaul of a packaging machine, relocation of a packaging line or a change of pack size. Care must be taken so that small, apparently insignificant changes do not accumulate and lead to unvalidated use.
Validation review may lead to full or partial revalidation and should take place regularly at intervals determined by knowledge of the process and usage of the equipment. Likely validation review intervals are in the order of two to five years.
More specific guidance would need a full knowledge of the packaging process, equipment used and the environment in which it is used.
No. These documents are subject to copyright and originals must be purchased. The Medical Device Directives and list of applicable standards are available on the Internet at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/.
Products that might be exposed to low atmospheric pressure, such as the pressure that occurs when an unpressurised aircraft makes an emergency ascent or when a product travels up a high mountain, must have a means of equalising interior and exterior pressure if the seals are not to be stressed. Peel seals may fail when the packaged air expands in a nonporous package.
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