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Three Crystal® equipment for pharmaceutical companies
Over the last 3 months, three contracts for Crystal® equipment have been concluded with pharmaceutical companies.
The first contract is related to the installation of a Laboratory Crystal® M1 Filling Station within the Cell Therapy division of Lonza in Walkersville (MD, USA). The equipment has been installed in January and is now operational. Lonza, after performing in-depth analysis of its compatibility with cryopreserved cells, took the decision to offer the closed vial platform to cell therapy clients.
The second equipment will be provided to the Nederlandse Vaccine Instituut (NVI) for the purpose of filling stability and clinical batches of vaccines either developed by this company or by other companies collaborating with them. This equipment is a Laboratory Crystal® L1 Robot Line having also the capability to fill and close glass vials.
The third equipment, of the Crystal® M1 Filling Station type, will be installed at Vivante GMP Solutions (Texas, USA) to fill various classes of injectable products, including high value products such as biological drugs.
About the equipment
The Laboratory Crystal® M1 Filling Station has been recently developed. It is designed to fill niche products with batches up to 1,000 vials. The equipment consists in a manual piercing tool, a laser cabinet and a capping tool. The operator performs all operations manually
Legend: the two main stations of the Laboratory Crystal® M1 Filling Station: the filling tool and the laser cabinet
The Laboratory Crystal® L1 Robot Line is designed to fill batches in the range of 1,000 to 5,000 vials. It consists in a robot performing the three operations with the vials staying in place in a rack.
Legend: overview of the core equipment of the Laboratory Crystal® L1 Robot Line
For more information about these lines, please call +32-81-409 410 or send an e-mail to info@aseptictech.com.
The complete range of vials is now available
Beside the already well known 1 and 2 ml vials produced by Injection Molding process, larger vials are now available made by Injection Blow Molding (IBM) to cope with the presence of vial shoulders. The complete Closed Vial Family offers the following nominal capacities: 1, 2, 6, 10, 20 and 50 ml.
These IBM vials are presently produced at pilot scale and manually assembled in clean conditions. They are gamma sterilized and released on the basis of their low particle and endotoxin content, and critical dimensions, making them suitable for stability and clinical batches at current stage.
The complement for the Validation Master Plan, completed for small vials, has been launched to gather the necessary information to support registration of IBM vials.
The next steps include the launch of a fully automated production process for IBM vials in S1 2011.
Legend: range of vials available, ranging from 1 to 50 ml vials
A new partner in the USA
PharmaSystems Inc., entered in partnership with Aseptic Technologies to act as commercial agent in several States in the USA. That partnership will be operational on April 1st. This partnership is seen as an excellent opportunity to reinforce our presence in this major area and to be closer to our US client.
To contact PharmaSystems: bmgiletta@pharmasystemsusa.com
Why a new technology to fill vials?
Regulatory requirements and guidelines for injectable drugs are continuously improving, looking for :
-Accrued quality of delivered products (e.g. quality ensured even without preservative1, reduction of silicone,…);
-Safer operations (e.g. cap crimping2 in Grade A / ISO 5, extensive use of Process Analytical Technology3, limited human intervention during aseptic operations4,…);
-Secured supply chain (e.g. anti-counterfeiting measures5 and product traceability at item level6).
All these new requirements and recommendations have to be integrated by producers - especially for aseptic filling – and lead definitively to additional complexity of the current technology, impacting dramatically both investments and operating costs.
Complying with these new coming standards and improving quality while reducing costs mean a real challenge for the coming years.
For that aim, Aseptic Technologies, a subsidiary of GSK Biologicals, has developed a new revolutionary technology for aseptic filling operations:
The Crystal® closed vial and its associated filling line.
The unique benefits this technology will offer to the Biotechnology and Pharmaceutical companies are:
- A ready-to-fill vial, provided closed, clean7 and sterile8, ensuring first class sterility assurance. During the complete filling process inside a non-access barrier, the vial is never opened, preventing any contamination. The Crystal® vial itself behaves as an isolator.
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Safer supply chain: made of COC9, the vial is very resistant to breakage, the risk of operator contamination is minimized, vial marking can easily be done on-line by means of RFID chip embedded in the vial itself, or by laser marking.
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Reduced investments and operating costs: less than half the clean room space is needed versus conventional filling lines, cost of equipment significantly cheaper,lean manufacturing thanks to the elimination of vial washing, no need of water for injection, no siliconization, no sterilization tunnel, no stoppering, no crimping, significant reduction in operating personnel, higher productivity.
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A solution largely preferred by end-users: market study has shown that 87% of the end-users (doctors, nurses and hospital pharmacists) prefer Crystal® vials compared to glass vials. The main drivers are ease of use, shock resistance, facilitated collection of liquid and improved asepsis.
2: EMEA/GMP/Annex1/Clause 93
3: FDA/Guidance for industry/PAT/Sept. 2004
4: Agalloco & Akers/The Truth about Interventions in Aseptic Processing
6: California serialization legislation passed House and Senate (2009 date)
7: Typically two times less particles than in traditional glass vials after washing
8: Gamma irradiated at 25 kGray
9: COC: Cyclo Olefin Copolymer – is a high quality USP Class VI plastic material, suitable for injectable drug containers – already used for PFS syringes - and compatible with visual inspection
FAQ’s
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The concept
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Is the Crystal®concept supported by FDA and EMEA?
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Both authorities have been informed on project status and did not raise any major concern. Moreover, the Belgian authorities have inspected the first operating Crystal®filling line and approved it as a GMP manufacturing facility. FDA classified closed vial filling as a modern manufacturing design, together with isolators (see link to FDA website below*)
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Is the Validation Master Plan completed?
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Yes (ICH ageing studies are on-going), all validation results are available to our clients who buy a line or wish to register a product
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The filling line
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Is a Crystal®filling line approved by EMEA and/or FDA?
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A first clinical line has been inspected and GMP approval has been obtained. Two DMF has been filed at the FDA (CDER and CBER).
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Is a Crystal®filling line in operation somewhere?
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A clinical line is in operation at our premises (Facility of the Year 2009 for Equipment Innovation). A second line is operational at Lonza in the US from Q1/2010 and GSK will install its first production line in 2010 (36.000 vials/h)
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The products
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Are there on-going stability tests?
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Research compatibility and official stability batches have been launched for many different products (GSK and third parties). In some cases, better stability were obtained with Crystal® technology
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Is my product stable in the closed vial?
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* link to FDA website, please refer to question 1
Participation of Aseptic Technologies at trade fairs and other events.
Aseptic Technologies is present at main pharmaceutical and packaging trade shows and scientific conferences around the world to present its revolutionary Crystal® technology.
These are the next events in 2010 where you can take the opportunity to learn more about the Closed Vial Technology
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Show
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Venue
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Date
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Type
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INTERPHEX
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New York, NY, USA
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20-22 April 2010
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Booth 946
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BIO Convention
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Chicago, IL, USA
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03-05 May 2010
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Booth 1838
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Biological Production Forum
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Frankfurt, Germany
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21-23 June 2010
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Table top
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ISPE annual meeting
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Orlando, FL, USA
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7-10 November 2010
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To be confirmed
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AAPS
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New Orleans, LA, USA
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14-17 November 2010
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To be confirmed
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