DAYTON, OHIO (June 16, 2010) – CSafe, LLC, www.csafellc.com, manufacturer of the AcuTemp® RKN active temperature controlled cargo container, and Cathay Pacific, one of the world’s top ten international providers of air cargo services, have signed a master lease agreement for CSafe’s active temperature controlled containers.
The agreement enhances the product offerings provided by Cathay Pacific’s PHARMA LIFT service in meeting the needs of healthcare and pharmaceutical customers that require strict temperature control of their products during transport. The FAA and EASA approved AcuTemp RKN offers the superior performance needed for shipping products with temperature requirements between +4 degrees Celsius to + 25 degrees Celsius.
“We have had much success with the use of the AcuTemp RKN and with it, have been able to offer our customers satisfied performance benefits of the unit,” said Jack Lo, Cargo Product and Marketing Manager of Cathay Pacific. “The heating and cooling capability of this unit, plus its ability to operate in extreme ambient conditions without the use of dry ice has been a welcome addition to our worldwide PHARMA LIFT product offering,” he said.
Validar um equipamento pode tornar-se uma tarefa sem fim. Estou reunindo neste Blog um pouco da minha experiencia de 15 anos validando equipamentos. Conto também com a sua contribuição para enriquecer este trabalho.
Mostrando postagens com marcador Notícias. Mostrar todas as postagens
Mostrando postagens com marcador Notícias. Mostrar todas as postagens
Três linhas de produção de vacinas do Instituto Butantan têm pendências
Fonte: Estadão.com.br/saúde - 11 de junho de 2010
Além da antirrábica, Instituto Butantan enfrenta problemas com as de hepatite B, tríplice e soros
SÃO PAULO - Além do suposto problema no fornecimento da vacina antirrábica, outras três linhas de produção de imunizantes do Instituto Butantan, ligado ao governo estadual, estão com pendências que impediram a revalidação do certificado de boas práticas de fabricação, segundo informações da Agência Nacional de Vigilância Sanitária (Anvisa).
Os problemas foram detectados na produção das vacinas contra hepatite B e tríplice bacteriana (difteria, tétano e coqueluche) e dos soros hiperimunes (contra picadas de animais peçonhentos). Excluindo a vacina da gripe, que é apenas formulada e envasada no Butantan, e a antirrábica, esses três produtos correspondem a toda a produção de soros e vacinas do instituto.
O presidente da Anvisa, Dirceu Raposo, afirmou ao jornal O Estado de S. Paulo que as pendências encontradas não oferecem risco sanitário e, por isso, a fábrica continua em funcionamento. Ele não revela, no entanto, que pendências são essas.
Além da antirrábica, Instituto Butantan enfrenta problemas com as de hepatite B, tríplice e soros
SÃO PAULO - Além do suposto problema no fornecimento da vacina antirrábica, outras três linhas de produção de imunizantes do Instituto Butantan, ligado ao governo estadual, estão com pendências que impediram a revalidação do certificado de boas práticas de fabricação, segundo informações da Agência Nacional de Vigilância Sanitária (Anvisa).
Os problemas foram detectados na produção das vacinas contra hepatite B e tríplice bacteriana (difteria, tétano e coqueluche) e dos soros hiperimunes (contra picadas de animais peçonhentos). Excluindo a vacina da gripe, que é apenas formulada e envasada no Butantan, e a antirrábica, esses três produtos correspondem a toda a produção de soros e vacinas do instituto.
O presidente da Anvisa, Dirceu Raposo, afirmou ao jornal O Estado de S. Paulo que as pendências encontradas não oferecem risco sanitário e, por isso, a fábrica continua em funcionamento. Ele não revela, no entanto, que pendências são essas.
Pesquisa de satisfação de clientes de certificação acreditada
O IAF (International Accreditation Forum) está gerenciando um projeto mundial para a coleta e análise de informações que possibilitem desenvolver ainda mais os princípios e práticas para a condução da avaliação da conformidade, o que fornecerá a confiança necessária para maior aceitação pelo mercado. A análise do feedback de usuários de certificação tem o objetivo de avaliar o valor da certificação acreditada. Atualmente a pesquisa on-line está sendo realizada em mais de 40 países diferentes.
Como membro pleno do IAF, o Inmetro está comprometido em coletar essas informações, para assegurar que a pesquisa alcance uma ampla representação de negócios, dentre clientes atuais e potenciais.
O IAF é a associação mundial de Organismos de Acreditação e de Avaliação da Conformidade, reunindo organismos interessados em avaliação da conformidade nos campos de sistemas de gestão, produtos, serviços, pessoas e outros programas semelhantes. Sua principal função é desenvolver um programa mundial único de avaliação da conformidade que reduza o risco para os negócios e seus clientes, garantindo a confiança nos certificados acreditados.
Para participar da pesquisa, acesse o endereço: http://ukas.iafcertification-brazil.sgizmo.com/
Como membro pleno do IAF, o Inmetro está comprometido em coletar essas informações, para assegurar que a pesquisa alcance uma ampla representação de negócios, dentre clientes atuais e potenciais.
O IAF é a associação mundial de Organismos de Acreditação e de Avaliação da Conformidade, reunindo organismos interessados em avaliação da conformidade nos campos de sistemas de gestão, produtos, serviços, pessoas e outros programas semelhantes. Sua principal função é desenvolver um programa mundial único de avaliação da conformidade que reduza o risco para os negócios e seus clientes, garantindo a confiança nos certificados acreditados.
Para participar da pesquisa, acesse o endereço: http://ukas.iafcertification-brazil.sgizmo.com/
New! Full immersion probes from Hart Scientific
The new 5606 and 5607 Full Immersion PRTs from Fluke's Hart Scientific Division are designed to perform in "full immersion" applications where both the transition junction and the lead wires must withstand temperatures covering the entire operating range of the probe. Such applications can include calibration or validation of sensors used in laboratory or bio freezers, walk-in refrigerators, autoclaves, ovens, stability test chambers, furnaces or incubators.
The Hart Scientific 5606 has a temperature range of -200 °C to 160 °C, while the 5607 has a range of 0 °C to 450 °C.
The 5606 is only 2 inches (50 mm) in length with a sheath diameter of 1/8 inch (3.1 mm). Since it can be fully immersed over its entire temperature range, users need not worry about calculating minimum immersion depth and can immerse the entire probe, transition junction, and lead wires in either non-corrosive liquids or dry mediums.
The 5607 has been designed specifically for performing calibrations or verifying the accuracy of sensors used in ovens or furnaces. Intended to be used in dry mediums only, the 5607 can be fully immersed in dry mediums over a temperature range of 0 °C to 450 °C. There isn't another PRT on the market that can be fully immersed over this range and remain as stable and accurate (± 0.05 °C). The lead wire of the 5607 is shielded with braided stainless steel and connected to the transition junction with a strain relief spring.
For more information and full specifications on the Hart Scientific 5606 and 5607 Full Immersion PRTs, go to http://www.hartscientific.com/.
By: Fluke Corporation [fluke@gcsemail.com]
The Hart Scientific 5606 has a temperature range of -200 °C to 160 °C, while the 5607 has a range of 0 °C to 450 °C.
The 5606 is only 2 inches (50 mm) in length with a sheath diameter of 1/8 inch (3.1 mm). Since it can be fully immersed over its entire temperature range, users need not worry about calculating minimum immersion depth and can immerse the entire probe, transition junction, and lead wires in either non-corrosive liquids or dry mediums.
The 5607 has been designed specifically for performing calibrations or verifying the accuracy of sensors used in ovens or furnaces. Intended to be used in dry mediums only, the 5607 can be fully immersed in dry mediums over a temperature range of 0 °C to 450 °C. There isn't another PRT on the market that can be fully immersed over this range and remain as stable and accurate (± 0.05 °C). The lead wire of the 5607 is shielded with braided stainless steel and connected to the transition junction with a strain relief spring.
For more information and full specifications on the Hart Scientific 5606 and 5607 Full Immersion PRTs, go to http://www.hartscientific.com/.
By: Fluke Corporation [fluke@gcsemail.com]
CSAFE CONFIRMS OPERATIONAL QUALIFICATION OF THE ACUTEMP RKN
AcuTemp RKN Proven Successful for the Transport of Temperature Sensitive Cargo
DAYTON, OHIO January 6, 2010 – CSafe, LLC, www.csafellc.com, provider of active container solutions for the temperature sensitive airfreight market, confirmed the successful Operational Qualification (OQ) of its AcuTemp RKN by three major pharmaceutical companies. Each company performed extensive and independent testing of containers at a wide range of temperature requirements across multiple shipping lanes, ambient conditions, varying payload sizes, and shipment durations. The consistent and successful results of the testing process by all three companies identify the AcuTemp RKN as a Qualified and reliable solution for transporting temperature sensitive healthcare products globally, particularly at 2°C to 8°C and especially where extreme ambient temperatures are encountered.
The AcuTemp RKN air cargo container is designed to eliminate the challenges associated with maintaining the cold chain for shipping temperature sensitive pharmaceuticals and biotechnology products. These products are often highly susceptible to damage or compromise due to insufficient temperature management as a result of inadequate packaging for the encountered ambient temperature conditions, dry ice irregularities, and transit delays. CSafe addresses all of these issues with its AcuTemp RKN which provides superior thermal efficiency, compressor-driven technology, and qualified operating capabilities for extended periods.
The Operational Qualification process employed for qualifying an active cooling and heating container along with the performance merits of the AcuTemp RKN were highlighted at IQPC’s 7th Cold Chain Distribution for Pharmaceuticals conference where pharmaceutical industry professional Geoffrey Glauser, Director Global Packaging Technology for Pfizer, presented an OQ test approach for active containers. As reported by Mr. Glauser, the AcuTemp RKN by CSafe maintained “exceptionally stable interior payload temperatures” when exposed to high and low ambient temperature extremes. Test results for summer and winter temperature profiles concluded the unit as “accepted for global shipping of drug substance and drug product with minimum and maximum mass/volume.”
“We are happy to report that the day-to-day working performance of the AcuTemp RKN accurately mirrors the performance and reliability testing performed by several large pharmaceutical and biotechnology companies,” states Oliver Bootz, vice president of business development for CSafe. “Not only have our customers experienced the superior performance of our active RKN versus dry ice or other compressor driven containers, its approval by both the Federal Aviation Administration (FAA) and the European Aviation Safety Agency (EASA) provides for the widest availability of global shipping lanes,” says Bootz.
Since it began service in 2008, the AcuTemp RKN is now in use by over 40 pharmaceutical companies and has consistently demonstrated its ability to maintain a customer-desired payload set-point, resulting in no recorded product loss. The container’s heating and compressor driven cooling capabilities eliminate the cost and environmental challenges associated with the use of dry ice, refrigerated trucking and internal packaging.
About CSafe, LLC
CSafe, LLC provides technology solutions for the temperature-sensitive air freight market. Its flagship product, the AcuTemp RKN, is the first and only active unit of its kind with both FAA and EASA approvals. CSafe has a worldwide network of logistics partners to address the stringent requirements of the temperature sensitive air cargo market. Headquartered near Dayton, Ohio, CSafe, LLC is a joint venture between AmSafe, Inc. and AcuTemp Thermal Systems, with locations in Washington State and Ohio and service center partners worldwide. For more information, visit http://www.csafellc.com/.
By: Linda Raisch [lraisch@csafellc.com]
DAYTON, OHIO January 6, 2010 – CSafe, LLC, www.csafellc.com, provider of active container solutions for the temperature sensitive airfreight market, confirmed the successful Operational Qualification (OQ) of its AcuTemp RKN by three major pharmaceutical companies. Each company performed extensive and independent testing of containers at a wide range of temperature requirements across multiple shipping lanes, ambient conditions, varying payload sizes, and shipment durations. The consistent and successful results of the testing process by all three companies identify the AcuTemp RKN as a Qualified and reliable solution for transporting temperature sensitive healthcare products globally, particularly at 2°C to 8°C and especially where extreme ambient temperatures are encountered.
The AcuTemp RKN air cargo container is designed to eliminate the challenges associated with maintaining the cold chain for shipping temperature sensitive pharmaceuticals and biotechnology products. These products are often highly susceptible to damage or compromise due to insufficient temperature management as a result of inadequate packaging for the encountered ambient temperature conditions, dry ice irregularities, and transit delays. CSafe addresses all of these issues with its AcuTemp RKN which provides superior thermal efficiency, compressor-driven technology, and qualified operating capabilities for extended periods.
The Operational Qualification process employed for qualifying an active cooling and heating container along with the performance merits of the AcuTemp RKN were highlighted at IQPC’s 7th Cold Chain Distribution for Pharmaceuticals conference where pharmaceutical industry professional Geoffrey Glauser, Director Global Packaging Technology for Pfizer, presented an OQ test approach for active containers. As reported by Mr. Glauser, the AcuTemp RKN by CSafe maintained “exceptionally stable interior payload temperatures” when exposed to high and low ambient temperature extremes. Test results for summer and winter temperature profiles concluded the unit as “accepted for global shipping of drug substance and drug product with minimum and maximum mass/volume.”
“We are happy to report that the day-to-day working performance of the AcuTemp RKN accurately mirrors the performance and reliability testing performed by several large pharmaceutical and biotechnology companies,” states Oliver Bootz, vice president of business development for CSafe. “Not only have our customers experienced the superior performance of our active RKN versus dry ice or other compressor driven containers, its approval by both the Federal Aviation Administration (FAA) and the European Aviation Safety Agency (EASA) provides for the widest availability of global shipping lanes,” says Bootz.
Since it began service in 2008, the AcuTemp RKN is now in use by over 40 pharmaceutical companies and has consistently demonstrated its ability to maintain a customer-desired payload set-point, resulting in no recorded product loss. The container’s heating and compressor driven cooling capabilities eliminate the cost and environmental challenges associated with the use of dry ice, refrigerated trucking and internal packaging.
About CSafe, LLC
CSafe, LLC provides technology solutions for the temperature-sensitive air freight market. Its flagship product, the AcuTemp RKN, is the first and only active unit of its kind with both FAA and EASA approvals. CSafe has a worldwide network of logistics partners to address the stringent requirements of the temperature sensitive air cargo market. Headquartered near Dayton, Ohio, CSafe, LLC is a joint venture between AmSafe, Inc. and AcuTemp Thermal Systems, with locations in Washington State and Ohio and service center partners worldwide. For more information, visit http://www.csafellc.com/.
By: Linda Raisch [lraisch@csafellc.com]
Assinar:
Postagens (Atom)


