Pharma Engineering Insights
Qualification of Pharmaceutical Water Sanitisat...
No GMP text fixes sanitisation temperature, concentration or frequency. The method for proving the sanitant reaches the worst-case location, handling residue removal, verifying microbial recovery and releasing the system back...
Qualification of Pharmaceutical Water Sanitisat...
No GMP text fixes sanitisation temperature, concentration or frequency. The method for proving the sanitant reaches the worst-case location, handling residue removal, verifying microbial recovery and releasing the system back...
Purified Water vs WFI: How to Select the Approp...
Assigning Purified Water or WFI to a point of use is a quality decision, not an engineering one. How to build the use, grade, rationale and documentary evidence matrix that...
Purified Water vs WFI: How to Select the Approp...
Assigning Purified Water or WFI to a point of use is a quality decision, not an engineering one. How to build the use, grade, rationale and documentary evidence matrix that...
Periodic Review and Retrofit of Pharmaceutical ...
The system still meets every specification, yet unplanned sanitisations keep increasing and the margin is thinning. How to build a periodic review that demonstrates the state of control, and how...
Periodic Review and Retrofit of Pharmaceutical ...
The system still meets every specification, yet unplanned sanitisations keep increasing and the margin is thinning. How to build a periodic review that demonstrates the state of control, and how...
URS for Pharmaceutical Water and WFI Systems: R...
A badly written specification produces bids that cannot be compared, qualification that cannot be defended and costs that only surface years later. Structure, method and criteria for building verifiable requirements...
URS for Pharmaceutical Water and WFI Systems: R...
A badly written specification produces bids that cannot be compared, qualification that cannot be defended and costs that only surface years later. Structure, method and criteria for building verifiable requirements...
Source Water and Pretreatment for Pharmaceutica...
Pretreatment is the least instrumented section of the plant and the most frequent cause of downstream excursions. Which source water attributes to characterise, over what period, and how to turn...
Source Water and Pretreatment for Pharmaceutica...
Pretreatment is the least instrumented section of the plant and the most frequent cause of downstream excursions. Which source water attributes to characterise, over what period, and how to turn...
Biofilm and Rouging in Pharmaceutical Water Sys...
Three microbiological excursions in six months closed as isolated events are a trend, not three incidents. How to investigate a pharmaceutical water system across sampling artefacts, biofilm and rouging, and...
Biofilm and Rouging in Pharmaceutical Water Sys...
Three microbiological excursions in six months closed as isolated events are a trend, not three incidents. How to investigate a pharmaceutical water system across sampling artefacts, biofilm and rouging, and...
