Printing Package

Considering the failure of available log D methods to predict in-house data and taking into account that such data are usually generated just for a few fixed pH values, a number of companies started to elaborate in-house methods for log D prediction at fixed pH. Up to date several companies have reported development of such methods. For example, Cerep has developed methods to predict log D at pH 7.4 and 6.5 included in their Bio Print package [107], but details of their method are not pubhshed. HQSAR Tripos descriptors were used by Bayer to develop log D models at pH 2.3 and 7.5 using 70000 (qi =0.76, STD =0.60) and 7000 (qi =0.83, STD =0.67) compounds, respectively [108] however, again, no details of the approach were provided. 

This section covers package decoration formats rather than the detail of their printing. Packaging that is delivered pre-printed, such as cans and drinks cartons, is covered in Sections 9.6-9.8. Decoration formats include labels that are stuck on to packages and heat-shrink plastic sleeves, which may be applied through a labelling technology or as a pre-made sleeve and heat-shrunk into place. 

Other factors to be considered include the effect on disposal of the plastic as a consequence of its being printed. Packaging is an important source of waste for disposal and not only the nature of the plastic but also that of the printing ink used must be assessed with regard to air, soil, and water quality after disposal. 

BRADLEY E L ct al., Test method for measuring non-visible set-off from inks and lacquers on the food-contact surface of printed packaging materials , FoodAddit. Contam., 2005 22(5) 490-502. 

VAN DEVENTER D and MALLiKARJUNAN P (2002), Comparative performance analysis of three electronic nose systems using different sensor technologies in odor analysis of retained solvents on printed packaging , J Food Sci, 67(8), 3170-3183. 

Labelling shall be informative and accurate. Samples of the printed packaging materials, including the package insert (or leaflet) and the product label should accompany the application for registration. 

Mock-ups of printed packaging matericil may be used for the sample(s) but must accurately reflect the legeil requirements of Regulation 9 (labelling requirements). 

The minimum legibility of print in the final printed package insert must at least be equivalent to that of 6 point Helvetica t5q>eface in black ink on white cartridge paper. 

Samples of the product in the intended packaging must be submitted with the application for registration. The smallest pack should be adequate except where other closure/container systems are used in which all the relevant sizes should be submitted. Mock-ups of the printed packaging matericil may be used but should accurately reflect the legislative requirements of Regulation 9. 

Specifications for starting materials (and also of primary or printed packaging materials) should include, if applicable, reference to a pharmacopoeial monograph. 

A frequent use of GC with polymers is in the quantitative determination of residual monomer and solvent content, even at sub parts per million levels. This is especially important in food contact applications (e.g. printed packaging materials) where taint and odour issues are important. There are a range of sample preparation and injection techniques to deal with a vast range of samples including, for example, headspace sampling where a solid can be incubated for a period of time and then the vapours from above the solid are transferred into the GC capillary. 

Printed packaging materials are considered critical to the conformity of the pharmaceutical product to its labelling, and special attention should be paid to the safe and secure storage of these materials. 

The purchase, handling, and control of primary and printed packaging materials shall be as for starting materials. 

Particular attention should be paid to printed packaging materials. They should be stored in secure conditions so as to exdude the possibility of unauthorized access. Cut labels and other loose printed materials should be stored and transported in separate dosed containers so as to avoid mix-ups. Packaging materials should be issued for use only by designated personnel following an approved and documented procedure. 

Outdated or obsolete primary packaging material or printed packaging material should be destroyed and its disposal recorded. 

Specifications for starting and packaging materials Specifications for starting and primary or printed packaging materials should provide, if applicable, a description of the material induding ... 

There should be standard operating procedures and records for the receipt of each delivery of starting material and primary and printed packaging material. 

Any significant or unusual discrepancy observed during recondliation of the amount of bulk product and printed packaging materials and the number of units produced should be investigated and satisfactorily accounted for before release. 

Each batch (lot) of printed packaging materials must be examined following receipt... 

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