New pharmaceutical processing and packaging event

image_thumb[1]PHARMA EXPO, a new exhibition for the packaging and processing of pharmaceutical, nutraceutical and medical device products, will co-locate with PACK EXPO Internacional, in Chicago, from 2 to 5 November 2014. The new event is co-organized by PMMI (the Packaging Machinery Manufacturers Institute, the owner of PACK EXPO shows) and ISPE (the International Society for Pharmaceutical Engineering). In addition to the exhibition, ISPE will host an international conference, covering packaging and processing technology and the challenges in the pharmaceutical lifecycle. For more information about PHARMA EXPO, click HERE.

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Gerresheimer acquired Triveni

Gerresheimer (Dusseldorf, Germany) acquired a 75% shareholding position in Triveni Polymers (New Delhi, India), a manufacturer of plastic containers and closures for the pharma industry with more than a decade production of regulated pharma packaging. Triveni, with 300 employees and a production site in  Kundli (Haryana Province, India), it was the first Indian company in 1995 to get approval by the American FDA (Food and Drug Administration) for crucial Drug Master Files (DMF) for plastic containers and closures. In the 2011/12 financial year, Triveni generated annual revenues of approximately EUR 20 M.

In April 2012 Gerresheimer took over Neutral Glass, a leading Indian manufacturer of pharmaceutical glass packaging products. With five plants in South America, six in China and now two plants in India, as well as a representative office in Moscow, Gerresheimer is well represented in the fast-growing emerging countries. Gerresheimer’s declared objective is to double revenues in the emerging markets from EUR 100m in 2010 to EUR 200m in 2013. In the financial year 2011 Gerresheimer achieved revenues of about EUR 140m in the emerging markets.

Single-use aseptic filling solutions

image Bosch Packaging Technology and Sartorius Stedim Biotech (SSB) announced a long-term global partnership agreement for the design and development of single-use filling solutions to be used on aseptic filling equipment from Bosch for final fill-and-finish operations of liquid pharmaceuticals. SSB will provide Bosch with pre-configured single-use filling transfer sets, consisting of bags, filters, tubing and connectors. Bosch will combine these sets with its aseptic filling and barrier isolation
technology to form new systems for aseptic filling, and exclusively market, distribute and service these new filling systems under the Bosch brand.

A European Standard for tamper-evident closures on medicine packaging

A European group of experts is currently working on a CEN standard for tamper-evident closures on medicine packaging. The backdrop to these endeavours are the so-called guidelines against counterfeiting for pharmaceuticals packaging approved by the EU in 2011. Besides the inclusion of security features, they also call for measures to safeguard originality: they should allow dispensing chemists to see whether packaging has already been opened and possibly had its contents exchanged. Because the guidelines do not specify the corresponding features, German pharmaceuticals companies and associations, as well as packaging companies have taken the initiative to specify the technicalities.
The basis is a DIN (German Institute for Standardisation) draft that was previously created by a German working group. The European working group will publish an initial draft this year.

image_thumb[1]The Edelmann Group (German supplier of paper/board based packs for pharmaceuticals) is represented in both working groups. Edelmann sees advantages in terms of manipulation prevention in particular among folding cartons with constructive tamper-evident closures. In terms of packaging technology, the CElock system is special as tabs are torn along a perforated line upon opening. This means that the original act of opening remains visible. The system was recently used again in the packaging solution realised by Edelmann for the blood-pressure reducer Sevikar, a product from the Japanese  pharmaceuticals producer, Daiichi Sankyo.

GEPACK with EN 15593:2008 certification

image GEPACK, PET packaging specialist, obtained the certification according to EN 15593:2008 standard. The Certificate issued by TÜV Rheinland, confirms that GEPACK fulfils the requisites of the standard Management of Hygiene in the Production of Packaging for Foodstuffs.
Based on the HACCP principles, the EN 15593:2008 standard differs from the general ISO 9001:2008 Quality Management standard. GEPACK implemented an integrated system for Quality and Hygiene Management, in order to fulfil both standards.
GEPACK works exclusively with PET packaging, with a production capacity over 150 million units per year, including design, moulds, production and delivery. The company is well known by its ability to develop standard and special shapes, mainly for foodstuffs and pharmaceutical products. The 6000m² production facility in Portugal includes a certified Clean Room (ISO 6, Class FDA1000). GEPACK have a registered Drug Master File Type III (DMF Nº 23 955) at the US Food and Drug Administration (FDA) and is the first Portuguese company to obtain the EN 15593:2008 certification.

Filling of Ampoules and Injection Bottles in Combination

ARF 10×0, a new machine from Bosch Packaging Technology, is able to fill and close ampoules. It is a compact alternative for the small batch production of pharmaceutical products with production rates up to 120 pieces per minute. A special option is available to combine the filling of ampoules and injection bottles. image_thumb[1]
The new machine consists of 2 gassing stations (pre-filling and post-filling gassing), a two position filling station with servo controlled rotary valve piston pumps, and a digital flowmeter for the easy and thorough reproduction of the flame regulation for the closing of the ampoules. The ignition of the flame takes place automatically and can be easily activated from the machine’s operator interface. The machine is loaded with ampoules or injection bottles via an inclined loading station. The containers are then singularized by a scroll conveyer loaded into the transport starwheel, which runs with an indexing motion. The starwheel gently transports the containers, in a low particle and laminar friendly way through the working stations. The ampoules in the transport starweel at the closing station are taken by a special holder and rotated for closing. This process takes place without a rigid bottom or side guides, which guarantees an almost frictionless rotation of the ampoules. This process is on one hand gentler on the packaging materials and the other hand reduces the particle generation. Another step towards higher pharmaceutical safety is the pivoting motion of the removal grippers towards the back of the machine. In this way the laminar flow over the opened ampoule during the closing (melting) is not disturbed. Also the central flame exhaust as well as the disposal shaft for the ampoule tips are arranged such that the laminar flow is affected as little a possible.
Bosch will show the new machine during INTERPACK.

SisTrade software at Istanbul Packaging 2010

image SISTRADE, an engineering and consulting company in Information Systems for the printing and packaging markets, will be exhibiting at Istanbul Packaging 2010, from 16 to 19 of September.

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