Welcome to our preview of exciting news and developments from day 2 of this year’s CPhI exhibition in Frankfurt.
Frankfurt bear and bull
Moisture-control solutions
Clariant Healthcare is featuring an expanded line of Equilibrium-Stabilizer products at its booth during this year’s CPhI Worldwide event.
The expanded solutions include EQ-Pak packets, EQ-Can canisters, EQ-Stopper caps and EQ-Bag, which are designed to deliver humidity control in all phases of the drug-product development cycle.
“While hydrolytic degradation of drugs can be addressed by removing substantially all humidity entering the packaging using a desiccant, other pharmaceutical properties may require the use of products that maintain a specific range of humidity throughout the shelf life of a drug product or ingredient,” explains Elisa Le Floch, PharmD, Clariant Healthcare Packaging, business development manager.
EQ-Pak packets and EQ-Can canisters are specially engineered sorbents that can act as humectants (desorbers) and desiccants (adsorbers) simultaneously, maintaining a particular equilibrium relative humidity (ERH) inside product packaging. This line of standard equilibrium-stabiliser products can maintain ERH levels of 10%, 20%, or 30% to protect finished drug products in bottles or tubes, or to protect bulk ingredients (powders, capsules) in boxes or bags before, during, or after tabletting or filling operations.
Additionally, EQ-Pak packets (now available in a new range of sizes: 1 g, 2 g, or 2.5 g) or EQ-Can canisters can be used to provide relative humidity control for the contents of drug bottles or containers, while EQ-Stopper caps provide similar protection for tablets or capsules stored in tubes. EQ-Bags (37 g, 255 g, or custom sizes) protect bulk-quantity ingredients or products.
Hall: 4.2
Booth: 42L40
Website: www.clariant.com
Certified solutions
ChargePoint CPhI
Specialist in powder containment and aseptic transfer valve, ChargePoint Technology, is certified to supply solutions for hazardous environments at its Liverpool facility in the UK.
The company, which started the certification process earlier this year, now holds Atmosphere Explosive (ATEX) and International Electro Commission (IEC) Explosive (Ex) equipment certification for the most stringent of explosive hazardous environments.
“Recent investment in our production facility, combined with achieving the highest level of certification in ATEX and IECEx form an important part of our strategy to continue to develop and offer superior containment solutions worldwide,” explains Christopher Eccles, CEO at ChargePoint. “In an industry that is so tightly regulated, we are very proud to boast complete transparency with the highest quality standards, not only from our in-house manufacturing but also beyond to our external partners who are also audited and certified as part of this accreditation.”
“This external certification is recognition of the work that we have put into suppling products suitable for use in the most stringent hazardous environments,” comments Adam Bunyard, director of innovation and technology at ChargePoint Technology. “In addition to our type-certified products, we have also conducted extensive testing of our out-of-scope products, enabling us to provide a unique level of support to customers during the Hazard Ignition Assessment phase of each project.”
Hall: 4.0
Booth: 40G42
Website: www.thechargepoint.com
Providing pharma outsourcing globally
Pharmaceutical services provider, PCI Pharma Services, is using CPhI Worldwide as a platform to reinforce its position as a leading global pharmaceutical outsourcing provider.
Earlier this month, PCI announced its focus on further European growth with the acquisition of Dublin-based pharmaceutical and healthcare contract packaging services provider, Millmount Healthcare — giving additional footprint within the EU.
Most recently, the company has aligned its business unit operations under new brand identities — the organisation will continue to operate under the core ‘PCI Pharma Services’ name, with sub-branding introduced relevant to distinct areas of the business:
- PCI Manufacturing Services
- PCI Clinical Services
- PCI Commercial Packaging
“We strive to position PCI to best support our clients in bringing new medicines to successful commercialisation. Our continued investment to expand our specialist service offerings mean we are able to provide clients with a full service from early stage development and manufacturing, through the clinical stages and ultimately commercial launch including serialisation,” states PCI president and chief executive officer Bill Mitchell. “As all elements of the service operate within one company, we are able to ensure a seamless transition as products move through the cycle of development to commercial launch. The introduction of sub-brands provides clarity for our clients on the nature of our service offer, while maintaining overall brand confidence.
“Since 2012, the business has gone through significant change focusing on strategic investments, acquisitions and expansion to deliver a strategy developed to best support our client needs with a model of industry-leading expertise, world-class facilities, and cutting-edge technologies. This unique blend enables us to build effective and long-term partnerships truly adding value to our clients.”
Hall: 4.1
Booth: 41F30
Website: www.pciservices.com
Expanded GMP manufacturing offering
Idifarma CPhI
Spanish contract development and manufacturing organisation (CDMO), Idifarma, is announcing the expansion of its GMP manufacturing offering with the installation of new automatic capsule filling capabilities at its EU-GMP approved plant in Pamplona.
The Bosch GKF-702 automatic capsule filling machine is now fully operational and will support Idifarma in the manufacture of small-scale clinical and commercial batches in addition to providing the company with the ability to simulate industrial production environments during R&D.
“The latest addition to our facility in Pamplona is a fantastic development for Idifarma, helping us to bolster our manufacturing capabilities and reinforce our position as a specialist CDMO for small-scale niche products in solid oral forms,” states Luis Oquiñena, general manager and co-founder of Idifarma. “The GKF-702’s modular design will help us to future proof our investment ensuring that we can add real value to our clients’ manufacturing and development projects over the coming years. It is important for us to remain versatile and flexible, however we will continue to focus on specialised low-volume and high potent pharmaceutical products which is a key differentiator for us.”
Included in the new investment is a minibowl for small R&D batches, which is also equipped with an industrial PC (IPC) that is 21 CFR Part 11 compliant and benefits from a variety of interfaces.
Furthermore, the company reveals that it has also recently invested in new analytical equipment at its Pamplona facility, including an Agilent gas chromatography system and dissolution apparatus, as well as four new Waters HPLCs to support its growing client base.
Hall: 9.0
Booth: 90F90
Website: www.idifarma.com
Flexible SPE
Available from Steelco is the Stopper Processing Equipment system (SPE) for cleaning, sterilisation, siliconisation and drying process with an easily configurable and flexible discharge system.
Over the past 20 years there has been a focus on the challenge of transfer of components, such as stoppers, plungers and crimp seals to filling machines installed in isolators. The challenge has driven innovation and led to the development of vessel docking and transfer systems with good success. It has however, until now, been largely semi-automatic, relying on manual docking of containers and manipulation of transfer chutes for discharge into the isolator.
Furthermore, such systems have largely been focused on high capacity/high speed lines, and not entirely suited to the smaller, lower speed lines that are increasingly common for biologics and other smaller batch products, or manufacturers with multiple smaller scale lines designed for operational flexibility, such as contract manufacturers.
The new SPE system addresses these requirements of a more flexible approach. Based on the well-established ICOS LST, the adaptable discharge system provides a direct connection to an isolator for a fully automatic and continuous feed of closures to a high-speed line, or discharge to sterile containers or bags (RTP ported or heat sealed) for transfer within a facility to smaller and/or multiple lines. Additionally, the SPE has multi-mode flexibility for any production scenario and is a good addition to Steelco’s portfolio of equipment for pharmaceutical production.
Hall: 4.0
Booth: 40H10
Website: www.steelcospa.com/en
Spray drying technology
Micro-Sphere CPhI
Micro-Sphere, a contract development and manufacturing organisation (CDMO), is adding a new spray drying technology to its services, in response to increased customer demand.
The new GEA PSD-3 spray dryer will extend the company’s spray drying capacity for both aqueous and organic solvent based formulations at the GMP manufacturing site in Switzerland.
“Customer demand for GMP spray drying is increasing and this latest investment strengthens our production capabilities whilst also reaffirming our niche expertise in the market,” says Dr Michele Müller, Micro-Sphere founder and president of the board. “The market response to our investment in our facility in Switzerland has been excellent and we are now implementing the upgrades and changes needed to offer greater capacity to handle larger quantities of pharmaceutical powders and commercial volumes of finished dosage forms.”
Hall: 6.1
Booth: 61B32
Website: www.micro-sphere.com
Data collection plug-in
Serialisation software provider, SEA Vision, and packaging machine manufacturer, Marschesini Group, are collaborating to launch a new data collection plug-in that is designed to improve efficiencies during pharmaceutical manufacturing.
This new plug-in will complement the solution providers’ serialisation offering and will enable users to analyse the overall equipment effectiveness (OEE) of pharmaceutical manufacturing lines, alongside performing serialisation.
“One of the greatest barriers to serialisation compliance is the cost of implementing new systems and processes, and that is why we are focused on helping our customers to achieve wider benefits to help justify the investment,” explains Marco Baietti, commercial director at SEA Vision. “Our latest research found that just 44% of companies intend to use the serialisation implementation process to achieve wider business benefits. We believe this is a missed opportunity and have made it our mission to help our customers to understand and realise the potential of serialisation technology.
“Of course, there are standalone tools that can perform OEE calculations on the market, however the additional cost to implement this functionality alongside our serialisation software is marginal. Additionally, third party devices often require additional integration, creating another unnecessary barrier to quick compliance. As a result, the plug-in is an efficient and cost-effective way of utilising the serialisation challenge to improve line operation.”
The new functionality afforded by the plug in means that the operator can have a holistic view of the line’s efficiency. Additionally, through using the visual reporting tool, the OEE of each line can be analysed in real-time while the batch run is occurring. Furthermore, any rejections and errors are recorded by the plug-in, meaning that a complete audit trail is generated.
“We have a long-established relationship with SEA Vision, having worked together for more than 10 years. This latest innovation is the next step in our goal to help pharmaceutical manufacturers improve efficiencies and leverage the benefits that new technology can bring to their lines,” adds Elena Stupatska, production manager at the Marchesini Group (Neri Division).
Hall: 4.0
Booth: 40G65
Websites: www.seavision.it and www.marchesini.com