Burgopak Ltd., exhibiting in Stand B6 at Pharmapack, will be showcasing its award-winning pharmaceutical packaging optimised for production on the company’s new Bosch Sigpack machinery. A patented sliding mechanism presents and secures blister packages and patient information booklets. Structural integrity extends package lifespan and ensures that the patient retains the entire pack intact at all times.
Four basic designs can be adapted to meet user requirements and accommodate nearly any pill, blister, or leaflet size. Burgopak currently offers single-blister, double-blister, dual-product single blister, and child-resistant and senior-friendly designs. Burgopak’s latest addition to its pharmaceutical series has achieved the U.S. Consumer Product Safety Commission’s F=1 child-resistant and senior-friendly standard.
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Burgopak reports that the patented sliding mechanism’s uniqueness and complexity discourages counterfeiting and piracy. Burgopak can also incorporate anticounterfeiting features in its packaging.
Alpvision will be showcasing in Stand B4 its full range of invisible solutions for protection against counterfeiting. Along with its Pharmapack presentation entitled “Low-cost effective invisible anti-counterfeiting solutions to protect primary and secondary packaging and labels” describing the pharmaceutical applications for the Cryptoglyph invisible marking technology, AlpVision will present its Fingerprint solutions for the first time in Europe. The system provides identification of original products without any additional marking and can be applied to the tablets themselves as well as to packaging that contains moulded or injected parts, such as the closures of jars, autoinjection systems, or other containers. Ordinary office flatbed scanners or mobile telephone cameras are sufficient to instantly verify whether a product is an original or a fake. AlpVision offers licenses and software that can be installed in the original manufacturer’s IT systems for production management.
Scanware will display the recently launched LYNX-SPECTRA 3D in Stand D20. The first pharmaceutical quality control system in three dimensions offers advantages for low-contrast testing tasks such as recognising deformation and fragments.
Gerresheimer Group, exhibiting in Stand A3, offers PharmaPlus, a highly controlled production process for producing glass syringes in its German competence center in Bünde. The new production line transforms prefabricated borosilicate tubes into PharmaPlus syringe barrels using advanced process steps.
The patented process cuts the tubes extremely smoothly and precisely, ionized compressed air removes tiny particles, and new-type precision tools form the syringe cone and finger flange. Advanced pick-and-place technology utilizing PEEK components minimizes glass contact with metal while servomotor-controlled feed systems take items through individual forming stations.
After cooling and surface treatment, syringes pass securely into a cleanroom. Optical inspection monitors dimensions and cosmetic imperfections. In addition, all critical process parameters are digitally recorded so that the manufacturing process is reproducible at any time.
Gerresheimer also offers sterile RTF (Ready-to-
Fill) systems, pen systems with matched glass and plastic components from a single source, caps and dosing that fit numerous molded-glass bottles and vials and a wide range of plastic packaging.
Gerresheimer has also expanded its offerings for drug delivery in China with a third plant, which opened in February in Danyang.
Top Clean Packaging Group will showcase its wholly integrated range of services for the pharmaceutical field in Stand C10. The group comprises five companies established in France, the Netherlands, and China, each of which is an expert in a specific plastic process. Located in China and ISO 9001 certified, Cartolux-Thiers (ISO 13485, ISO 9001, and ISO 14001 certified) offers ISO Class 7 cleanroom thermoforming (blisters, wedges, foams, protective caps, assembly cards, surgical kit packaging, handling trays, and other technical parts). Top Clean Silicone is specialised in liquid silicon rubber (LSR) injection moulding in a cleanroom environment. Processed materials range from standard to highly technical such as medical-grade silicon; thermoplastics injection moulding and packing take place in ISO Class 7 and Class 8 cleanrooms. Top Recycling is specialised in plastics recycling and recovery, processing waste from French and foreign companies. Top Clean Packaging offers the benefit of a global support, provided by a single supplier, including project design, implementation, and follow up. At every step in the process, designers and technicians are able to act on materials compatibility, packaging reliability, and cost effectiveness. The group also provides such services as process qualification according to IQ/OQ/PQ rules.
In Stands E19 and E21, Rexam Pharma will highlight its preservative-free multidose eyedropper solution. Overcoming the challenge of creating an ergonomic multidose device, Rexam created a device that is able to calibrate droplets, which can improve compliance. Novelia is compatible with existing filling lines, can handle a wide range of drug viscosities, and is easier for patients to use, the company claims. The key requirement for such a device is the microbiological sterility for treatment duration. Novelia has been tested and confirmed content and drop sterility for 28 days.
West Pharma will exhibit a variety of products at Stand E30. Among the products to be displayed will be the Daikyo Crystal Zenith prefillable syringe system. These ready-to-use syringe system components offer pharmaceutical and biopharmaceutical companies a total solution that can mitigate the risks associated with glass syringes. The silicone-oil-free prefillable syringe system helps protect packaged drugs by reducing exposure to extractables and silicone oil, thereby minimizing potential leachables in the drug product and reducing the risk of protein aggregation caused by silicone oil in the drug product.
In Stand C13, CB Automation (division of Bettinelli F.lli S.p.A) will offer equipment to guarantee the correct assembly of the pharmaceutical valve, detects the valve dose value by analysing the air pressure ongoing in the time. The dose control system consists of a couple of mechanical heads (one for “air input” and one for “air receipt”), pressure transducers and electronic cards for data acquisition. A light pressure is previously created in the transducer chamber owing to the compression of the receipt head gasket. This preliminary operation is carried out to check the leakage of all the upper circuit. Afterwards an upper cylinder “opens” the valve and lets enter in the receipt head exactly the air volume consisting in the valve dose. This air input creates a pressure increment in the receipt head, directly proportional to the dose volume. The pressure ongoing is visualised by a chart on a PC. The control parameters (time on X axis and pressure on y axis) allow the identification of the valve dose volume and the discrimination of the not compliant valves. The control system calibration is realised by means of certified gauges. The system PC automatically records all the control results for each valve tested.
Hekuma has developed an advanced automation line for the production of pipette tips with a cycle time of less than 5 seconds. The company will detail the technology in Stand D30. Using the latest drive technology and innovative, weight-optimized take-out gripper, the Hekuma side entry robot has a maximum acceleration of more than 9G. The mold open time is approximately 0.45 sec. Thus product cycle times of 4.9 sec and less are possible. Essential parts of the cleanroom-compatible take-out gripper are milled in one piece out of a solid block of aluminium. The system checks each pipette tip for outer and inner diameter precision.
Printing International, in Stand C05, uses new ultra-high quality CHIRON Ring Print equipment for printing on plastic and aluminium medical devices of different shapes in one or multiple colours. Quality can be controlled with optional camera and individual rejection. If required, Printing International’s machinery is manufactured for clean room environment in accordance with cGMP standards. Full GAMP validation papers can be provided. Machine operational software is also 21 CFR part 11 compliant. Printing International uses a large supply of FDA-approved pads and USP Class VI inks for all applications.
APE, a provider of self-adhesive labels, film, and more in Stand D14, will present BI-ETIQ and TRI-ETIQ to communicate more information. The BI-ETIQ solution is a Twin Label with three printed pages, whereas the TRI-ETIQ comprises five printed pages. They can be easily and cleanly opened and closed.
Don’t miss the growing number of exhibitors at BioMedDevice France, which include a number of providers offering drug-delivery technologies and other solutions for combination products. For details, visit http://www.devicelink.com/expo/biofrance10/exhibitor_list_en.html
