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Sep 17, 2019 (posted viaProZ.com): Currently translating and reviewing the documentation of a power plant in Brazil. The job comprises the entire technical specifications for the plant. Love it! It's going back to my roots as an electrical engineer....more, + 2 other entries »
"Translation is not a matter of words only: it is a matter of making intelligible a whole culture."
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Freelance translator and/or interpreter, Verified site user
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English to Portuguese - Rates: 0.06 - 0.07 USD per word / 25 - 30 USD per hour Portuguese to English - Rates: 0.06 - 0.07 USD per word / 25 - 30 USD per hour French to English - Rates: 0.06 - 0.07 USD per word / 25 - 30 USD per hour French to Portuguese - Rates: 0.06 - 0.07 USD per word / 25 - 30 USD per hour Spanish to Portuguese - Rates: 0.06 - 0.07 USD per word / 25 - 30 USD per hour
Spanish to English - Rates: 0.06 - 0.07 USD per word / 25 - 30 USD per hour
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Sample translations submitted: 1
English to Portuguese: Control of Drup Product General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Validation of Analytical Procedures
The majority of methods for drug product testing are identical to those used for release testing of drug substance.
They are performed according to the analytical procedures described in section 3.2.P.5.2.with the corresponding description of method validation provided in section 3.2.S.4.3.
Analytical methods applied for drug product (and not applied for release testing of drug substance) are described in section 3.2.P.5.2.
The tests: visible particles, sterility, uniformity of dosing units, sub-visible particles, and extractable volume are all performed according to the indicated pharmacopoeal monographs (current edition).
For these methods, matrix interference testing is only applicable for sterility testing. Accordingly, method validation has been performed for sterility testing (Ph. Eur. 2.6.1, USP (membrane filtration method)) and is summarized below.
Furthermore, determination of Polysorbate 20 content is performed for drug product as the only non- compendial method that is not already used throughout drug substance testing.
Accordingly, a method validation summary is provided below.
Compendial Analytical Methods for Drug Product (not performed for DS)
Visible Particles
Particulate contamination with visible particles is evaluated using the black-white square method according to Ph. Eur. 2.9.20, USP .
No specific validation is required for this test.
Uniformity of dosage units
Determination of the uniformity of dosage units is performed according to Ph. Eur. 2.9.40, USP .
No specific validation is required for this test.
Sub-visible particles
Particulate contamination with sub-visible particles is evaluated according to Ph. Eur. 2.9.19, USP , method I.
No specific validation is required for this test.
Extractable volume
The extractable volume is evaluated according to Ph. Eur. 2.9.17, USP .
No specific validation is required for this test.
Sterility
Sterility testing of dinutuximab beta Drug Product is performed according to Ph. Eur. 2.6.1, USP (membrane filtration method).
Summary of Method Validation
The general description of the membrane filtration method for sterility testing is given in Ph. Eur. 7th edition, 2.6.1 and in USP 36 .
Suitability of the sterility test method was shown with six representative strains of micro-organisms tested during the validation using dinutuximab beta drug product.
No matrix interference or growth inhibition could be observed.
Microorganisms were spiked into dinutuximab beta DP (batches 1018750 and 1019189) and results are shown in Table 2.
Translation - Portuguese Validação de procedimentos analíticos
A maioria dos métodos para testes de medicamentos é idêntica aos dos testes de liberação de fármacos.
Eles são realizados de acordo com os procedimentos analíticos descritos na seção 3.2.P.5.2.com a descrição correspondente da validação do método fornecida na seção 3.2.S.4.3.
Os métodos analíticos aplicados ao medicamento (e não aplicados no teste de liberação do fármaco) são descritos na seção 3.2.P.5.2.
Os testes: partículas visíveis, esterilidade, uniformidade das unidades de dosagem, partículas subvisíveis e volume extraível são todos executados de acordo com as monografias farmacopeicas indicadas (edição atual).
Para esses métodos, o teste de interferência da matriz é aplicável apenas ao teste de esterilidade. Consequentemente, a validação do método foi realizada para testes de esterilidade (Ph. Eur. 2.6.1, USP (método de filtração por membrana)) e está resumido abaixo.
Além disso, a determinação do teor de Polissorbato 20 é realizada para o medicamento como o único método não compendial que ainda não foi usado durante o teste do fármaco.
Consequentemente, um resumo de validação de método é fornecido abaixo.
Métodos analíticos compendiais para medicamentos (não realizados para DS)
Partículas visíveis
A contaminação por particulados com partículas visíveis é avaliada usando o método do quadrado preto e branco de acordo com o Ph. Eur. 2.9.20, USP .
Nenhuma validação específica é necessária para este teste.
Uniformidade das unidades de dosagem
A determinação da uniformidade das unidades de dosagem é realizada de acordo com Ph. Eur. 2.9.40, USP .
Nenhuma validação específica é necessária para este teste.
Partículas subvisíveis
A contaminação por partículas com partículas subvisíveis é avaliada de acordo com o Ph. Eur. 2.9.19, USP , método I.
Nenhuma validação específica é necessária para este teste.
Volume extraível
O volume extraível é avaliado de acordo com Ph. Eur. 2.9.17, USP .
Nenhuma validação específica é necessária para este teste.
Esterilidade
O teste de esterilidade do medicamento dinutuximab beta é realizado de acordo com Ph. Eur. 2.6.1, USP (método de filtração por membrana).
Resumo da validação de método
A descrição geral do método de filtração por membrana para teste de esterilidade é fornecida em Ph. Eur. 7ª edição, 2.6.1 e na USP 36 .
A adequação do método de teste de esterilidade foi demonstrada com seis cepas representativas de microrganismos testados durante a validação usando o medicamento dinutuximab beta.
Não foi observada interferência na matriz ou inibição do crescimento.
Os microrganismos foram adicionados ao dinutuximab beta DP (lotes 1018750 e 1019189) e os resultados são mostrados na Tabela 2.
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Translation education
Graduate diploma - Associação Alumni
Experience
Years of experience: 22. Registered at ProZ.com: Jun 2016.
English to Portuguese (Associação Brasileira de Tradutores) English to Portuguese (American Translators Association, verified) English to Portuguese (Brazilian Gov't, verified) Portuguese to English (Associação Brasileira de Tradutores) Portuguese to English (Brazilian Gov't, verified)
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Bio
I started my professional career as an Electrical Engineer, specialized in the area of Optical Communications, graduated by USP - University of São Paulo. However, my love for languages and linguistics opened a new path and I started translating for colleagues and teachers during my Masters degree. After that, translation started taking an increasing part of my time, interest and education. So I decided to attend a specific course to become a trained Translator/Interpreter.
In 1999, I became a Sworn Translator, role that I play together with my preferred areas of Technical Translation in IT, Computing, and Engineering. I am active member of the translation community. I write for ABRATES Magazine, I am currently a Mentor in the Mentorship Program, guiding and teaching starting translators. I taught Technical Translation in Associação Alumni, the same institution where I studied to become a translator.
I am still an Engineer at heart, and technology enchants me. I am constantly studying new technologies, especially those applied to my field.
I believe the combination of my formation as Engineer and the love of languages makes me an ideal professional for your technical needs.
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