vicentexxx
Beginner
Posts: 16
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Hi everyone,
I beg your pardon for this apparently simple question:
what's the difference between mix-up and cross contamination??
thank you in advance
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IHN1
Member
Posts: 174
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In response to vicentexxx
Mix up relates to the control of components, containers, closures or equipment
Contamination relates to the chemical properties of the drug product or intermediate.
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JohanJ
Member
Posts: 228
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In response to IHN1
As I see it,
Mix-ups is having a components of product A ending up in the manufacturing process of product B.
Cross contamination is more used for processes when fractions of something can contaminate a batch due to bad cleaning of equipment or environment, due to workflows of either material and personnel.
Cross contamination is rather something you can prevent by good design, and also procedures whereas mic-ups can be prevented mostly by good procedures invoking good practices.
cheers
Johan
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Rocky Bell
Beginner
Posts: 7
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In response to vicentexxx
It is my thinking that-
- Both are accidental happening during manufacturing.
-Mix-up is more referred as sizable amount of accidental mixing of one product/Material with another whereas corss contamination refers to accidental contamination of one product with residue of API of other product.
-Cross contamination more frequently referred in case of contamination with dust of API carried in atmophere.
any inputs in my thoughts are welcome.
Rocky.
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Kevin at Sanyo
Beginner
Posts: 40
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In response to Rocky Bell
In my experience, the two had a bit of grey area in determining which was more correct.
Mix-up was always thought to be the mixing an incorrect ingredient into a formulation.
Cross contamination was always determined to be minute or trace additions of a contaminant to a ready batch or ingredient.
Kevin Loomis
Validation Engineer
Sanyo Biomedical Solutions
(630) 694-8218
(800) 858-8442 x8218
kloomis@sss.sanyo.com |
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complianceguru
Beginner
Posts: 23
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In response to vicentexxx
It is my thought that mix-ups occur when the incorrect components are used in the manufacturing process. Components can include API and raw materials.
Cross-contamination can occur as a result of contamination caused by manufacturing equipment.
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