Tablets & Capsules

TC0520

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12 May 2020 Tablets & Capsules the packaging process. These materials include camera- inspected aluminum-based foils as well as specialty, high-barrier, and anti-counterfeiting polymer films that provide exemplary protection against moisture, oxy- gen, light, and gases. Premium-grade, cold-form base foil made from vali- dated raw material sources that are compliant with global regulatory standards serves as an ultra-high barrier pack- aging solution and can increase a product's shelf life. Working with this grade of foil will not only ensure that you meet product protection standards but will also provide advantages, such as exceptional formability and sealability with common lidding materials and high delamination resistance when used with primer. Stability testing and distribution Once your product is pack- aged, it's important to ensure that it remains potent, pure, unadul- terated, and safe over time. In the pharmaceutical industry, this is done through stability testing. The NACB addresses sta- bility testing in its "Standard 4.05. Sampling Integrity" [3]: "a. When selecting test samples for laboratory testing, a cannabis establishment shall use procedures that produce samples that are reasonably representative of the batch. "b. A cannabis establishment shall not alter the sam- ples or expose them to irregular conditions intended to manipulate the results of laboratory testing. Comment: One example of a practice that would violate Standard 4.05(b) would be the use of an ozone generator on a sample to eliminate microbes prior to testing in a way that does not reflect how the rest of the batch was treated." Packaging is also critical to distributors, who may require seamless product tracking and reporting. Finding the right tracking and reporting system for your prod- uct can be challenging, but new solutions that meet or exceed traceability and anti-counterfeiting requirements for the pharmaceutical supply chain are available. A com- prehensive tracking solution must address: • A unique identifying number for each consumable package; • Aggregated bundles and pallets for shipping; and • Geolocation to track the products through distribu- tion (from distributor to warehouse to dispensary) and to counter the grey market. When you're adopting a new tracking and reporting process, this is also a good time to consider heightening your branding efforts to create brand differentiation and awareness and strengthen brand loyalty. Regulatory outlook While many manufacturers are waiting for clarity on FDA regulation before entering the CBD market, com- panies continue to introduce minor CBD products, and PVC properties can be adjusted to various physical specifications. For example, the typical water vapor trans- mission rate (WVTR) of a 250-micron PVC film is 2.79 g/m 2 per day at 38°C and 93 percent relative humidity, and the typical oxygen transmission rate (OTR) is 25 c 3 /m 2 per day. By choosing the thinnest PVC film that meets your CBD product's required WVTR and OTR, you can minimize production costs while still meeting the quality requirements for your blister packaging. PVC packaging film for canna- bis products can be laminated to a thin layer of another polymer— such as polyvinylidene chloride (PVDC), polychlorotrifluoroeth- ylene (PCTFE), or cyclic olefin copolymer (COC)—to achieve better WVTR and OTR proper- ties. It can also be coated with PVDC to improve packaging pro- ductivity. PVC film can also be tinted with pigments containing additives to tailor the packaging to a product's needs, such as for ultraviolet light filtration. Cold-form films are ideal for blister packaging phar- maceutical or cannabis products, which require a high degree of protection against light and moisture. Cold- form films consist of biaxially oriented polyamide (BOPA), aluminum, and PVC layers that are laminated to each other using a cold forming process. Also, cold- form foil (CFF) is becoming more popular as the num- ber of moisture-sensitive drug products on the market increases. CFF is the only material that provides a 100 percent barrier to moisture, oxygen, and light. The combination of materials used to produce CFF gives the blister packaging the critical properties needed to meet the highest standards of protection for sensitive pharmaceutical and cannabis products, while providing exceptional formability and depth during Photo 1: A wide range of films and foils can be used for blister packaging applications for various cannabis formulations, such as CBD oils in capsules. Cold-form films are ideal for blister packaging pharmaceutical or cannabis products, which require a high degree of protection against light and moisture.

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