PACKAGING AT - 80 °C
When it comes to packaging medication, safety is a top priority. Generally, medication needs to be transported at between -2°C and -8°C. Within the European Union, there is a standard, termed Good Distribution Practice, for transporting medical products. The guidelines, which were adopted in 2013, define how to handle human medical products safely and regulate parameters such as temperature, cleanliness, safety and humidity.
Special requirements apply for the newly developed vaccine solutions. They need to be kept at a constant temperature of -80°C. This is the case because development was incredibly rapid. Manufacturers cannot yet make substantiated statements on the storage life of the medicine due to the lack of valid stability data for the corona vaccine.
For such low temperatures, simple styrofoam cases with dry ice just won’t get the job done. In order to package the corona vaccine safely, special containers with vacuum insulated panels which work like a thermos flask are being considered for shipping. These panels use extremely effective cooling elements to constantly keep the sensitive corona vaccines at the required temperature over several days. According to statements from the manufacturer, ice cubes retained their shape and temperature for around three weeks when stored in the box in trials during the summer months.
Other providers use active powered cooling components to provide safe packaging for the corona vaccine. However, electric power must always be available throughout the entire transportation and storage period for this, which is tough to implement in remote corners of the globe such as Africa or South America. Here, mobile transportation solutions are advantageous as they also ensure that the hotly anticipated corona vaccines safely get to where they are urgently needed, even in a heat wave. In any case, the temperature must be constantly measured in degrees and documented by intelligent packaging and sensors over the entire transportation route and beyond. Refrigerators must also be available in the warehouses so that the cooling chain is not interrupted
15 MILLION COOLING BOXES ON 200,000 PALLETS
A study by the DHL logistics group and McKinsey, a consulting company, in conjunction with non-governmental organisations, made it clear that the challenges involved in distributing the vaccine were very great indeed: To dispatch 10 billion units of the vaccine, 15 million cooling boxes need to be transported on around 200,000 pallets, in 15,000 cargo flights. “It’s no small feat to ensure that such a vital consignment can be transported around the world and delivered at -80°C,” explains Katja Busch, in discussion with the news agency Reuters. Busch knows what she’s talking about: as Chief Commercial Officer at DHL, she also attends to customers in the pharmaceutical industry.
Air freight capacity worldwide has shrank duet to the corona crisis. Thus, passenger aircraft will have to be used to distribute the corona vaccine, according to industry experts. The challenge also lies in providing the cooling facilities on board the aircraft. Safety regulations for air transport only allow a limited amount of dry ice. We have a mammoth task ahead of us, in which vaccine manufacturers, logistics groups, airlines, packaging and processing industries must work hand in hand with governments and the healthcare industry in order to ensure success.
Any marketing expert will tell you that regardless of how good your product’s quality is compared to your competitors, it will never sell unless it’s in an equally pleasing packaging. The importance of appealing and convenient packaging solutions can never be underestimated. But for a majority of small-sized products, finding the right kind of packaging isn’t as big of an issue.
Digital Medication Management plus First-Opening Indication: Schreiner MediPharm Equips Cap-Lock Security Label with RFID Technology
Equipping syringes containing liquid medications with RFID-Labels poses a challenge. Both the container material and the composition of the liquid may impair reading of a UHF RFID-Label. Flag labels protruding from the container are frequently used for this purpose. However, they can easily tear off, require additional space and have to be manually applied.
By working in close partnership with customers, Schreiner MediPharm develops in-depth knowledge of their production processes, as well as their legal and technical requirements. This results in intelligent products that fit perfectly within existing production processes and optimize them. Schreiner MediPharm customers can rely on a partner who provides them with comprehensive advice and optimum solutions for their challenges–from development all the way through to commercial production.
Polar Leasing Expands Availability of Cold Chain Storage to Meet Growing Demand in Biotechnology, Medical and Pharmaceutical IndustriesNews:
“Polar Leasing has prioritized an additional 300 new walk-in refrigerator and freezer units from our manufacturer Polar King International to satisfy the surging demand for both short and long-term rentals across the United States and Canada,” said Bart Tippmann, president of Polar Leasing. “We have now expanded beyond 80 distribution depots across the United States and, in some cases, can deliver orders within 24 hours.” He adds, “Custom controlled cold rooms can also be manufactured to customer specifications.” According to Polar Leasing, order processing is easy. Simply call the customer service hotline (866-574-4573) to reserve a leased unit with a digital signature. Standard 8’ x 10’ and 8’ x 20’ units are in stock, while custom sizes from 6’ x 8’ up to 16’ x 65’ are available in select markets or available to be built. Once the customer determines the required size, a free-standing walk-in unit is shipped and a roll-back truck puts it in place. “Ninety percent of the time we drop the unit right where the customer wants it,” says Tippmann. “We have fork slots in the frames to enable easy moving.” He explains, “Customers simply connect the unit to their electric source and installation is complete. When the rental has run its course, the truck picks up the unit and returns it to the depot.” Polar Leasing says there are advantages of using a ground-resting unit over a refrigerated truck. The NSF-approved walk-ins have a 6 ” step, as compared with the awkward ramp-and-door configuration of trucks. The units have a fiberglass interior with lights. Plus, they are dual temp to allow customers to go from a cooler to a freezer by the flip of a switch. Polar Leasing supplies many pharmaceutical companies involved in temperature-sensitive distribution. From research and development to the clinical trials phase, pre-conditioning gel packs or prior to transport, Polar Leasing temperature controlled cold room rentals are the perfect on-site solution for temporary refrigeration anywhere throughout the cold chain. Polar Leasing maintains all temperature controlled cold rooms by offering 24/7 service, optional dataloggers and RFID tags, temperature validation reports and custom options for long-term rentals. “Environmentally, the Polar Leasing solution is better than refrigerated trucks which are very loud and exhaust diesel emissions,” Tippmann notes. “Most importantly,” he adds, “the operational cost savings are substantial.” Polar Leasing 8’ x 20’ temperature controlled cold rooms are walk-in combination freezer/refrigeration units, specifically designed and engineered for customers operating in the pharmaceutical cold chain. Each custom-built cold room has an option of rental validation. For added efficiency and to further protect the integrity of the products stored inside, each cold room features vinyl strip curtains to reduce the amount of cold loss or heat gain. Each DT820P and DT820RED are constructed with a heavily reinforced door that is large enough to fit a hand pallet jack inside for loading and unloading. For customers that require larger storage space in which handloading is not an option, temperature controlled custom cold rooms are an ideal fit. Additionally, the heavy duty (HD) floor is durable and capable enough to hold up to 1,000 lbs. sq. ft., while the pallet duty floor is rated up to 5,000 lbs. sq. ft. For added safety and protection, the DT820P and DT820RED cold room units have an interior pallet bumper guard around the interior to prevent damage to the rental unit. As with all Polar King Leasing NSF-approved refrigeration rentals, the company offers an antimicrobial gel-coat finish on the interior to inhibit the growth of microorganisms, including bacteria, viruses, mold and mildew.
Brain health and mental wellness supplements company Heights has pioneered a new dimension in e-commerce packaging—and it’s only 25 mm, or 0.9 in., deep. The impossibly thin shipper, with an even slimmer, 23-mm bottle inside, was designed by the London-based company to easily fit through a U.K. letterbox-style mailbox. Being unique is not new for this start-up company; its distinctive supplement uses “capsule in a capsule” technology whereby the dry ingredients are in one capsule that is suspended in an outer capsule of Omega 3 oil. Says the company, “Most vitamins need to be taken with food or a fat-soluble substance. Because ours comes ready-made inside Omega 3 oil and dissolves slowly in your lower intestine, you get more of the nutrients reaching your bloodstream than in traditional pills, which break down too early to be effective. An added benefit to this—no nausea.” Specifically designed to give the brain the fuel it needs to improve its health and performance, the easy-to-swallow “smart capsules” are made from natural ingredients—among them, B12, blueberry extract, and 16 other essential vitamins—in the most biologically active form and are augmented with educational content for consumers on how to optimize brainpower. Says Heights co-founder Daniel Murray-Serter, “We use all natural nutrients and no synthetic fillers or caking ingredients and track your journey with us from day one, sharing insightful content from the world’s leading experts to help coach you on your journey to mental wellness.” Heights began working on the package design in early January 2019 with design firm Pentagram. The project was led by Pentagram partner and industrial designer Jon Marshall. Explains the firm, because Heights is a D2C brand, the design of the bottle was driven by two factors: It needed to be highly distinctive in order to launch the brand, and it also needed to be less than 25-mm thick to fit through the letterbox for efficient delivery and a great customer experience. Adds Murray-Serter, “We were 100-percent committed to fitting through the letterbox for environmental reasons, accessibility, and the ability to send internationally as a large letter. That was the starting challenge for the design project in general.” Foregoing the usual cold, science-like design language used by supplement brands, the clear 60-ct bottle for Heights’ supplements has a soft, asymmetric “thought bubble” shape and is flat on front and back to reveal the distinctive capsules inside. A narrow neck tapers into the main body of the bottle, making it easy for consumers to remove the daily dosage of two pills at a time, while still ensuring the bottle can be easily filled during the packaging process. According to Pentagram, the design team used a combination of software simulation and extensive development and prototyping with the (proprietary) blow-molding manufacturer and with the bottle filling line to achieve the distinct bottle shape. In order to minimize the shipper’s carbon footprint and stay within the 25-mm overall package thickness for economic delivery, Pentagram engineered the special shipping box so that it adds just 2 mm to the thickness of the product. The package comprises a hinged tray fitted with movable inner trays that securely hold the bottle and product literature and can be swapped out for future Heights’ products. Besides being letterbox-friendly, the entire package is also very eco-friendly—a must for Heights. “The packaging had to be best-in-class for sustainability because we have always planned from day one to qualify as a B Corp,” explains Murray-Serter. While the initial bottle design was tested and pre-launched using PET plastic, the final, commercial-scale version uses biodegradable, bio-based polylactic acid (PLA). The shipper is constructed of sugarcane-based pulp, and the information inside the package is printed on recycled paper. Heights launched the e-commerce product in the mail slot-compatible shipper in November 2019. Says Murray-Serter, “The response has been phenomenal. We’ve had customers tagging themselves in places like the Alps, on beaches, and as far as Easter Island, just to show off the amazing bottle design.”
Dosepak and IMC’s Med-ic work well together, we have proven that with hundreds of thousands of co-packaged Med-ic/Dosepak clinical trials blisters, marketed as Cerepak™
Features & Benefits
Med-ic enabled Cerepak: • Tracks date, time and location of dispensed pill
• Adherence-enhancing design is based on Dosepak®
• Hidden electronics are unobtrusive to patients
• Easy to manufacture using standard techniques
• Cost effective and simple to use
• Develops interaction with patients
IMPROVEMENT IN TOPICAL & TRANSDERMAL APPLICATION Patients can today easily find deposition systems for liquid and semi-liquid drugs, but they face a real lack of suitable application systems for these formulations, in particular if looking for precise and hygienic dosing with pharma-applicators. This is even more the case when a combined deposition and application is required. Current application systems like cotton tips, flocked applicators, spatulas, nail polish brushes or fingers present major drawbacks such as a lack of sterility, application and dosage precision, poor hygiene and fibre detachment. Therefore, GEKA has adapted its proven technology used in cosmetics to provide systems that combine these two attributes to fulfil pharmaceutical and cosmetic needs. The systems use applicators with extremely delicate microbristles (Figure 1), resulting from many years of expertise in injection-moulding technology and patented processes (EP1465759B1, Method And Device Of The Production Of Brushes). These applicators allow users to uptake formulations under hygienic conditions and to apply these with high precision – even for the most sensitive and pinpoint application areas. As just targeted areas will be touched with the very fine bristles, an increased efficiency and reduced side effects of application are the result. CONTRIBUTION TO INCREASED COMPLIANCE & PERFORMANCE The benefits of microbristle applicators are: 1. Increased application precision (Figure 2): Track precision: bristles do not spread, but create a precise, continuous track Dot precision: bristles do not spread, but create a precise dot Targeted areas: MBA™ reach several areas with their adjusted rigidity and perfect resilience. 2. Increased dosage precision: The MBA™ technology and expertise in topography/design allows us to design applicators with specific shape and geometry for a defined load and release dose of the drug in a consistent and patient-independent way. 3. Guarantee of purity and hygiene: Pure pharma-grade plastics (e.g. LDPE) are used for production without additives, glues, metal or loose fibers. Automated production in one step Radio sterilisation at 25 kGy Depending on the design of the customised MBA™, a wide range of materials (polyolefin and TPE) can be offered. 4. Guarantee of traceability: Full traceability up to the raw materials is ensured. Microbristle systems are not limited to a specific application field and can be used for various market segments (as shown in Figure 3) such as: Dermal care (Rx medicated skin care dermatology, OTC skin care, cosmetic skin care) Oral health care, e.g. mucus membrane treatment, aphthae Dentistry, e.g. easing dentists’ gestures Dental for patients, e.g. bleaching treatments, interdental brushes Eye care, e.g. drops and ointment, infections, sty, lashes/brow treatments Hair / scalp treatments Animal health Ear / nasal / foot / rectal / vaginal care Diagnostics. TEST METHODS & RESULTS GEKA Healthcare can provide services such as sharing methods or realising customised tests using its specifically developed Performance Test Method, for example, to evaluate dosage pick-up and release, or calculation of standard deviation to monitor the consistency of application. Therefore a specific machine with a movement precision of 0.1 mm, included camera system and exact scale is used. This test system was created in collaboration with Ansbach University of Applied Sciences (Figure 4) and allows us to recreate the movement of the applicator during usage by consumer (various positions and angles of the applicator) and to measure uploaded and released quantities of formulations. Dosage Precision Increase The graph in Figure 5 illustrates the difference between standard polyamide (PA) brushes and the GEKA Healthcare MBA™ for the uploaded dose (dose “charged” on the applicator and ready to be applied on the skin) and for the released dose (dose effectively applied on the skin). The product used is water and the system used is the dip-in applicator 28730. In conclusion, the difference between uploaded and released quantity is over four times smaller when using an MBA™, rather than the PA brush. Dosage Precision Consistency Figure 6 illustrates the consistency of dosing for a standard PA brush and for a MBA™ applicator. The product used is water and the system used is the dip-in applicator 28730. The standard deviation is more than ten times smaller for the released quantity with MBA™ compared with a standard PA brush, which means much higher consistency of dose really applied to the patient. The standard deviation for the uploaded quantity is also much smaller for the MBA™. DESIGN & PLATFORM NEEDED FOR A SPECIFIC TRANSDERMAL USE Different designs GEKA Healthcare offers MBA™ in different shapes and sizes, for example with 4.7 bristles per mm². Figure 7 shows convex and concave applicators, applicators with reservoir zones and comb-, brush-, and paint-type applicators. Upon test methods, the specific applicator topography is designed to perfectly match the drug characteristics (e.g. viscosity, surface tension). The length of bristles, space between bristles, bristle density, entire wettable surface and the surface tension of the applicator material can be defined. Different Platforms MBA™ can be combined with various packaging systems as Figure 8 shows: a) Dip-in formats with single usage sticks The drug is contained in any standard bottle of customer’s choice and the single-stick applicator will be delivered beside the bottle. The quantity of sticks per patient is to be defined by the pharma company. The patient deposits a drop of drug on the applicator, and then applies it on the target. Once used, the single-usage stick can be thrown away. b) Dip-in formats with multi-dose packs A complete multi-use packaging is perfectly adapted for warts, scars and wound care. It can contain a small polyethylene terephthalate (PET) or polypropylene (PP) bottle equipped with a wiper ensuring the removal of excess product before the application and a screw-on cap equipped with an MBA™ applicator. The MBA™ can also be combined with temper-evident, child-resistant and standard screw caps with thread according to DIN 168. c) Dip-in single-dose blow fill seal (BFS) packs Together with rommelag (Buchs, Switzerland), a cost-efficient alternative to expensive and complicated dosing systems has been developed. BFS bottelpack® containers are aseptically formed, filled and sealed in one operation cycle in a closed environment. The dip-in microbristle applicator is inserted during the BFS process. The convenient, single-dose device allows for an intuitive, simple use combined with hygienic and precise deposition and application. It uses an advanced aseptic BFS process according to US Pharmacopeia, FDA and GMP guidelines. d) Flow-through tube ‘Twist’n’brush’ GEKA partnered with Neopac (Oberdiessbach, Switzerland), the packaging specialist for Polyfoil® high barrier tubes, to develop this singledose tube packaging. It is based on the original Twist’n’use™ closure system with integrated tamper-evident function: when the nozzle is twisted, the internal tamper-evident pin is detached and the liquid or semi-liquid contents can be applied precisely, without being contaminated. The ultra-fine, soft, pharma-grade plastic bristle brush allows a convenient and gentle topical application of the medicinal products, with utmost precision and hygiene. For medical applications (such as wound care) the entire tube and applicator will be sterilised with gamma rays prior to filling. In order to fulfil the maximum standards of quality, safety and consistency, GEKA manufactures under strict compliance with the stringent ISO 9001:2008 and applicable GMP guidelines. It guarantees complete traceability of production right down to the raw material. Also ISO 13485 and 15378 are proposed for new developments, as well as the completion of the necessary DMF. A cleanroom is available (particle limit value according to clean room class 8, ISO 14644) to produce under controlled atmospheric conditions.
Rectal cannulas suitable for heathcare, pharmaceutical and veterinary applications. The rectal applicator must be placed on the syringe Luer: compatible with Luer-Slip syringes (not compatible with Luer-Lock syringes). Because it is simple to use, this rectal delivery system is particularly adapted to paediatrics.
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