By 2013, barrier technology has become overwhelmingly accepted as the basis for new aseptic processing facilities. The traditional cleanroom facilities of the 20th century are being rapidly replaced with advanced barrier-based technology filling facilities. This technological evolution is dramatically reducing the risk of product contamination and risk of infection to the patients.
Barrier technology has progressed through several distinct generations of innovation. The 1st generation barriers appeared with the LUMs isolators in the 1990s. This technology was not fully embraced by the industry due primarily to the extended cleaning cycle and was quickly followed by the 2nd generation barrier-RABS technology. In 2002 the 3rd generation barrier was initiated with the launch of isolators with a greatly reduced sanitization cycle which also increased business applications for this technology. Over the past decade, these isolators have become the new standard. During the past year, a number of technological advances have been introduced by the premier aseptic filling line vendors in the industry. Combined, these advances have produced the 4th generation aseptic barrier technology.
The catalytic converter design for SKAN Isolators is made for performance with process guarantee from the H2O2 experts from Switzerland. This means today Isolators have decontamination cycles with a six log reduction and aeration of the containment down to 1 ppm residuals in two hours. With extensive tests runs at SKAN, the engineers found the material composition for best results. In total, the customer has a very low down time during decontamination of the filling machine and there is huge energy saving with the catalytic breakdown of the H2O2 process.
The wireless glove tester from SKAN, the most advanced and fully automated glove leak testing system with pressure decay measurement for isolators and RABS in the pharmaceutical industry is ready for shipment. A lot of improvements could be reached together with the pharmaceutical industry. The operation is simple without tubes and wires. All necessary functions to perform a reliable glove test are integrated in the battery powered test cover. The test method is monitoring the pressure loss of the glove/sleeve assembly over a defined time and has individual glove test recipes according the used material.
The SKAN Biological Indicators have reliable performance and the homogeneous quality and performance within one lot are most important during production. Therefore each lot is tested to performance and the GMP conditions for manufacturing are self-understanding. The customer hotline is supported from experienced process specialists who know very well about H2O2 processes and containments used for pharmaceutical manufacturer.
At the Groninger company innovation is a daily function, perhaps considered a way of life. A customer driven approach enables this focus. The recently introduced combination filling system is proof of that. It is able to provide our customers with plenty of options. Three proven pump systems, integrated into one filling station, with minimal footprint. Now you can find time-pressure, peristaltic and rotary piston pumps all together in the new, Kombi Filling Rack.
With 100% In-Process-Control at speeds of 400 a minute you no longer need to compromise speed for quality. The limits have been breached and expectations exceeded while coupling this technology with simple efficient contactless transport. Maximum output can be achieved by a unique handling method that eliminates glass to glass contact and above all is very fast.
To offer continued quality at significant speeds with Groninger a 3-fold camera system can be utilized. The system is put into place to monitor for glass particles as well as residues and deposits inside of objects. This camera system is integrated into multiple process steps while filling and closing to isolate issues before they have an opportunity to disturb the product. Please contact us to see how customer driven innovation can benefit you.
Bausch+Stroebel Machine Company is finding ways to improve quality, economics, ergonomics after the line is installed in your facility with equipment for washing, depyrogenating, filling, closing and labeling a variety of containers. “Precision to the Highest Standard” is our motto driving our employees to innovate and optimize the highest quality product ultimately serving the patient and our customer.
Flexible filling of vials, cartridges and syringes in pre-sterilized nests enables targeted batch sizes for high value biopharmaceuticals, effective capital investment for around the world, appropriate clinical production batch sizes all on the same filling line.
Liquid filling 300 upm at a lower target with 100% IPC improving yields to help manage the cost of goods for clinical production with limited API, small molecule products through high value biopharmaceuticals.
Container washing green, economics and ergonomics by conserving water, reducing utility requirements while at the same time improving the environment for your operators.
Dry heat tunnel processing in ISO 5 with durability to maximize filter life and product quality mitigating risks of filter failure and time consuming investigations in a critical area with limited environmental monitoring.
OPTIMA pharma’s latest innovation in vial filling and closing lines with barrier isolation technology, loading systems, and freeze-drying technology will be highlighted during the tour. An expanded range of new products and innovative high-value drugs, coupled with smaller batch sizes require state of the art technology for manufacturing equipment. The integration of 100% IPC in combination with advanced filling, re-stoppering and re-capping technology has proven itself as an important feature for high filling accuracy and reduction of valuable product loss. Disposable product path in combination with advanced filling systems, integrated outside of the isolator, ensures changeovers of product contact parts in less than 15 minutes. The barrier isolator with drastically reduced aeration time is an important milestone for reducing turnaround time and production efficiency. New catalytic aeration technology allows decontamination phases to be reduced by up to 50%, compared to traditional aeration methods.
rommelag® is moving forward in the pharmaceutical industry in two primary ways: higher capacity and more efficient Blow/Fill/Seal (BFS) systems, and leveraging our contract manufacturing resources to allow new products to utilize BFS technology. The high efficiency bottelpack® BFS systems have higher production rates with lower operation costs. These systems have given our customers an advantage over their competitors that utilize other packaging technologies. Our contract manufacturing sister companies, holopack and maropack, produce over 150 products for more than 100 customers. This knowledge base gives us the ability to move a product from clinical trials to full commercial production. We support our contract manufacturing Blow/Fill/Seal customers with the new BFS technology and product production capabilities. Maropack, located in Zell Switzerland, has taken Blow/Fill/Seal technology to a new level with the first BFS system installation into a BSL-2 compliant facility. This facility is designed to test and produce biological products: vaccines, antibodies, enzymes and immunological substances, and is capable to meet the higher personnel safety levels required to produce these products. Rommelag® has incorporated new cold chain controls into the BFS system that meet the standards that biological products typically require.
IMA LIFE is one of the few suppliers in the world that designs, manufactures and tests a full range of proven systems for fully automatic loading and unloading vials into industrial freeze dryers.
IMA LIFE has all the necessary expertise and production facilities in-house, ensuring the highest quality standards on the entire configuration. Systems for use with vials are trayless, operate at constant loading level and can be configured under laminar flow or fully isolated.
Bosch Packaging will be showcasing their expanding portfolio of equipment services to support the “complete” Aseptic Pharma manufacturing plant, from; continuous vial, ampoule and syringe fill lines, sterilizers, automated inspection, and device assembly and handling machinery. The global introduction of our newest generation of MLF vial fill equipment. The new MLF version will have patented, precision dose weight verification of up 100% of vials filled, at speed up to 400 vpm. This machine utilizes technologies developed on our intermittent and continuous motion fillers to provide the most robust. Key design elements include;
- Dosing technologies to minimize product loss at start-up, production and end of batch;
- Optimized gassing configuration to minimize residual headspace oxygen.
- “Anti-splash” function to minimize turbulence during vial transport
- Integral enclosure design to accommodate various RABS and isolator installation
Bosch will also be presenting the new ISS Rapid Transfer Isolator to allow for transfer of components, parts, etc. into isolator or RABS enclosure through an interconnected chamber that will surface sterilize these components utilizing Bosch SafeVAP vaporized H2O2 technology.
These examples are merely a sampling of the exciting advances that have created 4th generation barrier technology. They provide aseptic manufacturers with less contamination risk in product and component transfers, more efficient and dramatically reduced sanitization cycles, and reduced risk to patients.
Learn more about the 4th generation aseptic barrier technology at each of these premier equipment manufacturers through guided tours by the IPS aseptic SME team at the 2013 INTERPHEX show in New York in April.
This article originally appeared in the 2013 INTERPHEX Technologies Tours supplement from PharmPro.