Pharma Engineering Insights
FAT, SAT, IQ, OQ and PQ of Pharmaceutical Water...
No current text prescribes how many phases a PQ must have, how long it must run or how many samples it needs. How to build and justify the qualification chain...
FAT, SAT, IQ, OQ and PQ of Pharmaceutical Water...
No current text prescribes how many phases a PQ must have, how long it must run or how many samples it needs. How to build and justify the qualification chain...
How to Select a Pharmaceutical Water System Sup...
Three apparently equivalent bids only diverge at FAT, at the first proprietary spare part, at the first end-of-life notice. How to build RFI and RFP, evaluate bids at constant scope,...
How to Select a Pharmaceutical Water System Sup...
Three apparently equivalent bids only diverge at FAT, at the first proprietary spare part, at the first end-of-life notice. How to build RFI and RFP, evaluate bids at constant scope,...
TOC and Conductivity Monitoring in Pharmaceutic...
Eleven rising values within the limit are not eleven non-events. How to design measurement, alarms and review for the two attributes Annex 1 requires continuously, separating process data, alerting, compendial...
TOC and Conductivity Monitoring in Pharmaceutic...
Eleven rising values within the limit are not eleven non-events. How to design measurement, alarms and review for the two attributes Annex 1 requires continuously, separating process data, alerting, compendial...
Pharmaceutical Water Sampling Plans: How to Sel...
A sampling plan inherited from qualification does not survive an inspection. How to build the rationale that ties each point to a precise question, and how to tell a sample...
Pharmaceutical Water Sampling Plans: How to Sel...
A sampling plan inherited from qualification does not survive an inspection. How to build the rationale that ties each point to a precise question, and how to tell a sample...
Hot, Cold and Ozonated Pharmaceutical Water Sys...
The 70 °C in Annex 1 is an example, not a set point. How to compare hot, ambient and ozonated loops with equal rigour: control mechanism, weak points, recovery, materials,...
Hot, Cold and Ozonated Pharmaceutical Water Sys...
The 70 °C in Annex 1 is an example, not a set point. How to compare hot, ambient and ozonated loops with equal rigour: control mechanism, weak points, recovery, materials,...
Automation, SCADA and Data Integrity in Pharmac...
An excursion the historian never kept cannot be investigated. Data flow mapping, audit trail at the right layer, named accounts, a common clock, backup and restore: how to govern the...
Automation, SCADA and Data Integrity in Pharmac...
An excursion the historian never kept cannot be investigated. Data flow mapping, audit trail at the right layer, named accounts, a common clock, backup and restore: how to govern the...
