Glossary entry (derived from question below)
Spanish term or phrase:
Control higiénico
English translation:
Hygiene monitoring
Added to glossary by
sebaspedlp
Jan 2, 2017 13:40
7 yrs ago
3 viewers *
Spanish term
Control higiénico
Spanish to English
Medical
Medical: Pharmaceuticals
trabajo para facultad
Control higiénico**
Recuento de microorganismos aerobios totales: 102 ufc/g.
Recuento combinado de hongos filamentosos y levaduras: 101 ufc/g.
Ausencia por gramo de:
Staphylococcus aureus
Pseudomonas aeruginosa
Hygienic control?? Muchas gracias
Recuento de microorganismos aerobios totales: 102 ufc/g.
Recuento combinado de hongos filamentosos y levaduras: 101 ufc/g.
Ausencia por gramo de:
Staphylococcus aureus
Pseudomonas aeruginosa
Hygienic control?? Muchas gracias
Proposed translations
(English)
4 +2 | Hygiene monitoring | Iseult Harrington |
3 +2 | contamination control | Helena Chavarria |
Proposed translations
+2
30 mins
Selected
Hygiene monitoring
Hygiene monitoring to detect aerobic microbodies, microorganisms, etc. in a production environment
4 KudoZ points awarded for this answer.
Comment: "Thank you so much"
+2
35 mins
contamination control
The prevention and control of microbial contamination are critical for manufacturers of pharmaceuticals products to maintain quality and safety of medicines.
Some of the measures to prevent the microbial contamination of pharmaceutical products are given in the bullet list below.
http://learnaboutgmp.com/prevention-and-control-of-microbial...
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Note added at 43 mins (2017-01-02 14:23:54 GMT)
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Successful contamination control in pharmaceutical clean rooms calls for a multidisciplinary approach. Within an operational facility the microbiologists have their part in contamination control and monitoring, and the engineers theirs; so too have the production personnel, the quality, validation, logistics, technology transfer and compliance specialists. They have to communicate well and understand each other’s difficulties, they have to share knowledge, and they have to accept that responsibilities often overlap. They should appreciate that the greatest risks to contamination control most often occur at interfaces, not just at physical interfaces between areas designated for activities of differing vulnerabilities in the factory, but also at organisational and cultural interfaces between departments, and around topics where personnel with differing educational and vocational backgrounds are obliged to interact.
http://dlia.ir/Scientific/e_book/Medicine/Pharmacy_and_Mater...
Development of a contamination control plan is critical to the success of aseptic, terminal sterilization, and non-sterile manufacturing facilities. This is most obvious in the aseptic arena, where the US Food and Drug Administration has issued clear regulatory guidance on the need for control of contamination at all stages of the process. What is less obvious is the even greater need for a plan to address contamination control in non-sterile manufacturing. This need for contamination control in non-sterile manufacturing only becomes obvious after a problem has arisen, frequently a problem in contamination control that requires product recall.
http://microbiologynetwork.com/content/file/JVT_2012_v18n2_T...
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Note added at 57 mins (2017-01-02 14:38:14 GMT)
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Microbiological Contamination
Microbiological contamination refers to the non-intended or accidental introduction of infectious material like bacteria, yeast, mould, fungi, virus, prions, protozoa or their toxins and by-products.
http://www.safeinfusiontherapy.com/cps/rde/xchg/hc-safeinfus...
The correct term appears to be 'microbiological/microbial contamination', but that might be straying too far from the original text.
Any pharmaceutical product, whether manufactured in the hospital or industrial environment, has the potential to be contaminated with microorganisms. With sterile products, any microbial contamination presents an unacceptable risk; with non-sterile products, the implication of the contamination is dependent upon whether the microorganism can be considered ‘objectionable’, and then to the extent that it can cause patient harm (and here a risk assessment is ordinarily required).
Fungi are more evolutionarily advanced forms of microorganisms, as compared to the prokaryotes (such as bacteria). Fungi are commonly divided into two distinct morphological forms: yeasts and hyphae (or filamentous). Yeasts are unicellular fungi which reproduce asexually by blastoconidia formation (budding) or fission.
http://www.europeanpharmaceuticalreview.com/24118/topics/mic...
Some of the measures to prevent the microbial contamination of pharmaceutical products are given in the bullet list below.
http://learnaboutgmp.com/prevention-and-control-of-microbial...
--------------------------------------------------
Note added at 43 mins (2017-01-02 14:23:54 GMT)
--------------------------------------------------
Successful contamination control in pharmaceutical clean rooms calls for a multidisciplinary approach. Within an operational facility the microbiologists have their part in contamination control and monitoring, and the engineers theirs; so too have the production personnel, the quality, validation, logistics, technology transfer and compliance specialists. They have to communicate well and understand each other’s difficulties, they have to share knowledge, and they have to accept that responsibilities often overlap. They should appreciate that the greatest risks to contamination control most often occur at interfaces, not just at physical interfaces between areas designated for activities of differing vulnerabilities in the factory, but also at organisational and cultural interfaces between departments, and around topics where personnel with differing educational and vocational backgrounds are obliged to interact.
http://dlia.ir/Scientific/e_book/Medicine/Pharmacy_and_Mater...
Development of a contamination control plan is critical to the success of aseptic, terminal sterilization, and non-sterile manufacturing facilities. This is most obvious in the aseptic arena, where the US Food and Drug Administration has issued clear regulatory guidance on the need for control of contamination at all stages of the process. What is less obvious is the even greater need for a plan to address contamination control in non-sterile manufacturing. This need for contamination control in non-sterile manufacturing only becomes obvious after a problem has arisen, frequently a problem in contamination control that requires product recall.
http://microbiologynetwork.com/content/file/JVT_2012_v18n2_T...
--------------------------------------------------
Note added at 57 mins (2017-01-02 14:38:14 GMT)
--------------------------------------------------
Microbiological Contamination
Microbiological contamination refers to the non-intended or accidental introduction of infectious material like bacteria, yeast, mould, fungi, virus, prions, protozoa or their toxins and by-products.
http://www.safeinfusiontherapy.com/cps/rde/xchg/hc-safeinfus...
The correct term appears to be 'microbiological/microbial contamination', but that might be straying too far from the original text.
Any pharmaceutical product, whether manufactured in the hospital or industrial environment, has the potential to be contaminated with microorganisms. With sterile products, any microbial contamination presents an unacceptable risk; with non-sterile products, the implication of the contamination is dependent upon whether the microorganism can be considered ‘objectionable’, and then to the extent that it can cause patient harm (and here a risk assessment is ordinarily required).
Fungi are more evolutionarily advanced forms of microorganisms, as compared to the prokaryotes (such as bacteria). Fungi are commonly divided into two distinct morphological forms: yeasts and hyphae (or filamentous). Yeasts are unicellular fungi which reproduce asexually by blastoconidia formation (budding) or fission.
http://www.europeanpharmaceuticalreview.com/24118/topics/mic...
Note from asker:
Thank you! |
Peer comment(s):
agree |
Charles Davis
57 mins
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Thank you, Charles :-)
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agree |
Muriel Vasconcellos
: Your answers seem to cover both possibilities. In this case I see a difference between 'control', which includes prevention', and 'monitoring', which emphasizes tracking more than preventing.
9 hrs
|
Thank you, Muriel. In view of Liz's references I have done further research and I think 'hygiene monitoring' is basically related to the general work environment, not the product.
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Reference comments
5 hrs
Reference:
see
Note from asker:
Than |
Thank you!! |
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