P|A|C|K|A|G|I|N|G | S|P|E|C|I|A|L to comply with DIN 55559. Standards stipulate test procedures but not what the package needs to looks like. Packaging solutions, which have been tested successfully, were registered at the BFArM (Bundesinstitut für Arzneimittel und Medizinprodukte, German Institute for Pharmaceuticals and Medical Products) and are then entered in the Fo r t s c h r e i b u n g s l i s t e (Table 3). This list does not have to be complete as only those items are listed which are registered by pharmaceutical companies or packaging manufacturers. Material combinations past test according to the previous DIN 55559 still have to be tested according to the adult test in order to be compliant to DIN EN 14375. Type testing (Fortschreibungsliste) is valid for the tested package and in a sense for the product packed. Nevertheless there is no such regulation that the tests have to be repeated dependant of the geometry of the filling good. BS 8404 accepts the material combinations approved by the DIN standard. Changes of the material combination (e.g. 25 µm Al soft and COC, cross perforation) ask for a new test. Reason for this is mainly the distinct stiffness of bottom materials. For example for reclosable containers the largest and the smallest are Abilities/Difficulties of children and adults Abilities Difficulties Children Clamping, pressing, biting, tearing, hitting, do it with perseverance, eager to learn, imitation, experimenting with pleasure, visual preferences, fundamental positive attitude Combining, execute simultaneous and complex motions,reading, writing, strong force, semantic experience, finemotoric motions Adult Loss of force, weak vision, low contrast perception, low comprehension of new technical subjects, uncontrollablefinemotoric motions, loss of memory, mental block,typically negative approach to new thinks. Combining, simultaneous motions, reading, writing, pressing, clamping, biting, tearing, pulling, hitting, semantic experience, understanding, taste preferences. tested and it is assumed that the intermediate sizes will also comply with the criteria for CR/SF if it passes the tests. Reason for type testing: the number of children who have to participate in the tests is decreased. Australia In Australia the Therapeutic Goods Act 1989 is effective, Therapeutic Goods Order No. 65 “ChildResistant Packaging for Therapeutic Goods” (nonreclosable and reclosable packages). In this regulation also the therapeutic goods are stipulated which have to be packed in a child-resistant package. As to non-reclosable packages blisters or other single unit dose packages listed it is stipulated which specific material requirements have to be fulfilled. Test procedures are defined in AS 19281982. In the protocol of 1996 it is described that approved packages from Canada, the US or the UK will also be approved in Australia if an appropriate test certificate is provided. India The Indian standard IS 14233 (1995) “Packaging – Pharmaceutical Products – Child Resistant Tamper-Proof Packaging for Solid Dosage Forms – Code of Practice” is similar to BS 7236 and describes blisters and strip packs. The test of the package is not carried out with children but is a mechanical test. Japan In Japan there is no regulation/standard as to CR/SF. It is up to the pharma company whether and how to pack the pharmaceuticals with protection for children. Canada Here the Canadian standard CSA 276 C: Drugs I is effective. According to this standard a package is childresistant when compliant with CSA 276 (1992 last edition concerning non-reclosable packages), reclosable packages (1995), UK Standard BS 5321 and PPPA. New Zealand In New Zealand the standard NZS 5825 (non-reclosable and reclosable packages) is effective. Approval is granted by the Department of Health. Packages which are approved in Europe, US or Australia as child-resistant are also approved in New Zealand. Development and test of new solutions for CR/SF The pharma industry is looking for new packaging solutions for CR/SF. Some of the existing materials have been on the market for more than 20 years. The abilities of Table 4: Values of Barrier properties of Lidding Foils for CR/SF April 16-30, 2013 BAFArM No. Lidding foil MVTR (g/m² x d) ASTM F 1249-90 25°C; 100%r.H. OTR (cm³/m² x d x bar) ASTM D 3985-81 25°C; 50% r.H. 14 (19981) 30 (1985 50 g/m² coated paper/Al 9 µm/HSL (1) (2) 15 (1981) 30 (1985) 35 g/m² glassine paper/Al 9 µm/HSL (1) (2) 17 (1981) 30 (1985) lacquer/ Al 30 µm/HSL (embossed) < 0.01 < 0.005 23 (1982) 30 (1985) lacquer/Al 25 µm soft/HSL < 0.01 < 0.005 31 (1985) 50 g/m² paper/Al 7 µm /HSL (PVC) (1) (2) 42 (1991) 50 g/m² paper/Al 7 µm /HSL (PP) (1) (2) 43 (1991) 40 g/m² paper/Al 7 µm /HSL (PP) (1) (2) 52 (1999) 50 g/m² paper/Al 9 µm /HSL (PVC) (1) (2) 35 g/m² Kraft paper/Al 9 µm /HSL (PVC) (1) (2) protective lacquer/Al 20 µm, rigid/15 µm PVC < 0.01 < 0.005 protective lacquer /Al 20 µm, rigid/30 µm PVC < 0.01 < 0.005 protective lacquer /Al 20 µm, rigid/30 µm PP < 0.01 < 0.005 www.expresspharmaonline.com EXPRESS PHARMA 51

Express Pharma April 16-30, 2013