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To help reduce the risks of operator exposure and process cross contamination of powdered materials in the pharmaceutical manufacturing environment, the International Society of Pharmaceutical Engineering (ISPE) has published ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment.
Critical testing factors are identified
To help reduce the risks of operator exposure and process cross contamination of powdered materials in the pharmaceutical manufacturing environment, the International Society of Pharmaceutical Engineering (ISPE) has published ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment. The guide provides standard methodology for testing the containment efficiency of solids handling systems used in the pharma industry under closely defined conditions. The main factors that affect the test results for particular contained solids handling systems, such as material handled, air quality, room environment and operator technique, are also highlighted. The technical publication identifies the critical factors that need to be controlled during the test and details the essential features of the test room, along with a number of recommendations.
RPC Containers Market Rasen and RPC Containers Halstead have designed and manufactured new vitamin containers for Morrisons Supermarkets. The cylindrical containers incorporate a senior-friendly squeeze and turn tamper evident closure, which is injection-moulded and produced in eight colours to match the labels of different products within the range. Other features of the containers include a large label area to enable prominent on-shelf branding; they are extrusion blow moulded in white HDPE; and are available in 130 and 150 mL sizes.
"RPC's cross-site working has allowed Morrisons to benefit from the expertise of individual sites in, respectively, container and closure manufacture," commented John Bell, sales development manager healthcare at RPC Market Rasen.
For a cost-effective and efficient solution to clean-in-place applications, Bete Ltd (UK) offers a range of high-performance spray balls. Designed to meet the strictest hygiene standards, the devices are constructed in 316 stainless steel and contain no moving parts. Reported to deliver a constant and consistent rinsing action, the devices feature holes ranging from 1.3–2.5 mm in diameter — in a number of configurations — for either upward, downward or 360° spray coverage. In addition, the sprayers are resistant to a wide range of chemicals and cleaning fluids, and operate effectively up to a maximum temperature of 430 °C. Device widths range from 28–120 mm with clip-on inlet connectors.
Jetpharma Group is collaborating with suppliers (such as K-Tron Feeder Group and Malvern Process Systems) of equipment, services and instrumentation to the pharmaceutical industry through the presentation of several technical seminars. The free one-day events will include detailed process and analytical information about 'Current Advances in Micronization for the End-User and Manufacturer's Point of View Including Cryogenic Micronization Techniques'; 'Integrating the Most Efficient Feeder Technology for Your Continuous and Batch Processing'; 'Online Particle Analysis and Control for Process Uniformity and Quality; High Potency Containment Solutions Including Glove Boxes/Isolators'; and 'Continuous Pharmaceutical Processing via Twin Screw Extrusion for Controlled Solid Dosage Release Forms'.
Through a marketing agreement between Amcor Flexibles and Montesino, the industry will have access to blister simulation technology that can help pharmaceutical companies complete packaging studies more quickly and accurately, speeding up new drug launches and reducing testing costs. Black Box is capable of providing pharmaceutical packagers quantifiable projections of finished blister thickness at multiple points within each cavity, as well as corresponding barrier performance for each cavity using various blister film materials. This technology enables package development staff to base decisions upon quantifiable measures gained from years of research using finite-element analysis and experience with a wide spectrum of materials.
In a fight to combat counterfeiting, Sherwood Technology has developed a colour change technique that can be used for brand protection and security applications. Products are provided with their own unique mark, which is permanent, discreet and irremovable, and the colour change mechanism can be triggered by low power CO
laser light energy. DataLase technology can be used for a variety of covert and overt security applications whereby a product is overtly marked with a 'finger print' such as a tiny 2D Datamatrix code. DataLase Clear images enable the covert checking of a product's authenticity: they are undetectable and only become visible when exposed to energy from a low power CO
laser for authenticity verification.
"The application of DataLase technology for the purpose of security features is a very new and exciting project. Existing methods have become stagnant and predictable to counterfeiters who find ways around them. However, DataLase has the potential to revolutionize the market. We expect brand protection applications to be the key development areas for this technology," said Stave Kelly, managing director of Sherwood Technology.
The Avantis unit of Invensys Process Systems has introduced enhanced condition monitoring (CM) software that provides an effective early warning system for plant maintenance and operations. The software collects and aggregates real-time data from plant floor systems, and provides sophisticated analysis of that data to drive preventive and predictive maintenance activity. The CM solution is said to improve asset management by providing an early warning system that allows organizations to move beyond calendar-based maintenance into a proactive, asset performance-based maintenance environment. Furthermore, the software also empowers operators by providing the ability to track maintenance activity associated with an asset, without leaving the operational environment.
Niro's Courtoy MODUL tablet press has been improved by increasing operating time through an innovative automated washing system, Wash Off Line (WOL). According to the company, the tablet press contains all powder within an exchangeable compression module (ECM) designed for fast product changeover (often as little as 30 min) with very high containment. Furthermore, the WOL increases production time by cleaning the ECM after it is removed from the tablet press. The press system remains in operation producing another product while the cleaning cycle runs.
Delivery companies branch out into formulation development
Advances made in proteomics, genomics and biotechnology are breeding a new generation of therapeutics that require novel drug delivery systems for patients to receive maximum benefits. According to analysis reported in Drug Delivery: Analysis of Cutting-Edge Technologies and Trends, this, coupled with competition from lower-priced generics snapping at the heels of patent expirations is compelling pharmaceutical companies to investigate innovative drug delivery solutions. One opinion is that pharma companies are starting to realize that new delivery systems can improve the overall performance of drugs, as well as safety and efficacy.
Numerous drug delivery companies have also become more proactive in participating in the drug development procedure. "Drug delivery companies have already started to develop their own formulations, which they can combine with their drug delivery platforms," observes S. Ravi Shankar, Technical Insights research analyst from Frost & Sullivan. However, researchers are concentrating not so much on delivery techniques to enrich drug performance, but as a means by which to reduce dosage frequency, preferably through noninvasive methods. The most dominant technique will probably be the oral route, followed by the pulmonary route. Techniques already under development are customized oral drug release technology; drug-eluting beads; the use of polymers; and intelligent inhalers that automatically respond to breathing patterns for delivering precise drug doses.
Speaking recently at the Drug Discovery Technology conference in Europe, Murray Lumpkin, acting deputy commissioner, international and social programmes, FDA, warned that the pharmaceutical industry is at risk of losing its 'innovative' identity given the decreasing number of truly original drugs being approved by the agency. Placing a figure of $800 million (€617 million) on bringing a successful drug to market, Lumpkin noted the challenge to innovation is hampered by the increasingly lengthy and costly business of investment; the unpredictability of drug research; and the ever-changeful capital market and regulatory processes.
Of the potential products that start clinical development, four out of five do not make it to market. In a similar vein, 50% of drugs that undergo Phase III trials are revealed to be unsafe or lack efficacy. Therefore, the risks outweigh the benefits. Instead of taking a risk, many in the industry are choosing to work with established compounds and 'marketable' diseases, thereby shifting its emphasis away from curative and preventable interventions in addition to rare and less common diseases. However, Lumpkin did express that more effective, more targeted, individualized therapy is an advancement we can all look forward to.
The way future medicines are produced is about to change thanks to a grant of Â£6 million awarded to the University of Manchester to open the Manchester Centre for Integrative Systems Biology (MCISB). The centre will pioneer an entirely new approach to biology that will help pharmaceutical companies to develop better drugs in less time. To do this, MCISB will develop new methods of computational and mathematical analysis, which will then be used to create generic computational models with the potential to allow pharmaceutical companies to perform virtual trials of any medicine on any living organism.
Software to assist processes and quality
Formulation software is available from Mettler Toledo for the control and monitoring of formulation processes, and protection of product quality. FormWeigh.Net combines powerful formulation software with reliable weighing technology and uses up-to-date IT technology. The company claims its latest software offers fully traceable mixtures; fast and secure processes; clear, user-friendly representation of the weighing process; and prevention of valuable materials loss or wastage.
Recent concerns and uncertainties that have been expressed in the pharmaceutical industry about the origin of polishing compound components has brought Axium Process to the decision to use, exclusively, polishing materials that are certified to be free of all animal derived products. Where physically possible and appropriate, in-house orbital welding is used for weld reproducibility and integrity. The company's polishing team provides finish levels ranging from 0.8 Âµm to below 0.1 Âµm Ra (bright mirror polish), with or without electropolishing, for items such as final product handling equipment where surface finish is essential. Furthermore, Axium's capabilities range from the production of high-quality adaptors, jacketed assemblies and manifolds to the supply of fully integrated, customized hygienic process plants.
The Swiss company, Ferring Pharmaceutical, has opened a 20000 m
GMP-compliant manufacturing plant in Zhongshan Port (China). This expansion marks the company's first Asian production site. With its multiple production lines, including solutions for injections, lyophilized products, granules, and enema, the company aims to better serve patients, provide new and innovative medicines, develop pioneering technologies and strengthen business development in Asia.
NextGen Sciences, has opened a new US-based operation. To head this office, the company has appointed Cliff Turner as president. With more than 20 years' experience in sales and business development management in the life sciences sector, Turner replaces Andrew Creasey who is stepping back from the position.
"NextGen Sciences has an enormous commercial opportunity in the US market. I intend to work closely with the UK team and the US distribution network to maximize sales as the company continues to grow," commented Turner.
Biotech companies, as well as generics makers, are eyeing opportunities to develop follow-on protein products (FOPPs). Pressure is mounting for regulators and legislators to remove obstacles that block low-cost generic products from the markets. Generic drug makers are challenging the sale of "authorized generics" by innovators and are opposing legislation that would grant patent extensions to brand-name firms that conduct research on counterterrorism agents. FDA is examining ways to streamline its system for approving new generics for market.
After more than a year of discussion, FDA is moving to develop formal guidance for bringing "comparable," "equivalent" or "FOPPs" to market. The agency is under pressure to articulate a pathway for manufacturers to test and assure the quality of generic versions of biotech therapies as a way to reduce drug prices. The promise is that increased competition among biotech manufacturers could also limit the risk of shortages, encourage product improvements and avoid unnecessary human and animal testing.
Consensus is emerging that follow-on proteins may be similar and comparable, but not necessarily therapeutically equivalent, to innovator drugs. Thus, FOPPs may require testing and approval criteria that differ from those for conventional generic drugs, but less extensive than those followed by the innovator firm. Innovator firms insist that follow-on companies need to supply clinical trial data to ensure the safety and efficacy of protein products, but a compromise seems to be emerging. Most experts agree that a follow-on protein may not be identical to a comparator drug, but that it will be possible to document sufficient similarity to establish safety and efficacy.
Pharmaceutical manufacturers can now have access to the latest interpretation and use of legislation with the launch of an online service by Zenosis. The UK technology company provides an online e-learning and knowledge support service for global regulations and compliance for the international life science industry. Some of the world's leading drug companies, including AstraZeneca, Merck & Co. and Wyeth Biotech have already logged on so that they can train their staff in hundreds of different international directives, processes and procedures within a continually changing regulatory environment.
"Our aim is to help our customers focus upon what they do best; that is improving the quality of human life. We want to be able to help them get their products to market faster and stay there," commented Simon Burgess, CEO of Zenosis.
The EU Commission and EMEA have published several documents for consultation on their website. These documents revise some existing GMP requirements and also add some new ones. Titles of these papers include
Concept Paper Dealing With the Need for Updated GMP Guidance Concerning Dedicated Manufacturing Facilities in the Manufacture of Certain Medicinal Products
Inspections at Manufacturers of Active substances — Guidance on Grounds (Triggers) for Inspections — for Public Consultation
Detailed GMP Guidelines for Active Substances used as Starting Materials — Public Consultation
Authorizations for Manufacturing and Import & GMP Certificates — Form and Content for Public Consultation
Concept Paper on Revision of Annex 15 of EU GMP Guide