Pharma Engineering Insights
How to Select a Cleanroom and HVAC Supplier: RF...
Bids with different scopes are not comparable, and price rewards whoever leaves work out. How to build the RFI and RFP on the URS, assess engineering capability, CFD, service and...
How to Select a Cleanroom and HVAC Supplier: RF...
Bids with different scopes are not comparable, and price rewards whoever leaves work out. How to build the RFI and RFP on the URS, assess engineering capability, CFD, service and...
BMS, EMS and Environmental Controls for GMP Cle...
The BMS/EMS boundary is not a technical given but an architectural decision to be declared and justified. Which parameters are monitored, who holds the GMP record, how alarms are rationalised,...
BMS, EMS and Environmental Controls for GMP Cle...
The BMS/EMS boundary is not a technical given but an architectural decision to be declared and justified. Which parameters are monitored, who holds the GMP record, how alarms are rationalised,...
Airflow Visualisation Studies in GMP Cleanrooms...
A tidy video proves nothing if the scenarios are wrong. This article shows how to set the protocol, worst case scenarios, execution and interpretation of an airflow visualisation study, and...
Airflow Visualisation Studies in GMP Cleanrooms...
A tidy video proves nothing if the scenarios are wrong. This article shows how to set the protocol, worst case scenarios, execution and interpretation of an airflow visualisation study, and...
Cleanroom Qualification: ISO 14644 Tests, HEPA ...
Classification, qualification and routine monitoring are not the same thing. How to structure a cleanroom qualification package around the Annex 1 minimum test list, stating occupancy state, method and the...
Cleanroom Qualification: ISO 14644 Tests, HEPA ...
Classification, qualification and routine monitoring are not the same thing. How to structure a cleanroom qualification package around the Annex 1 minimum test list, stating occupancy state, method and the...
Requalification, Troubleshooting and Retrofit o...
§4.32 sets the minimum content and maximum intervals of requalification, but the frequency must be justified. How to read alarms and trends, isolate root cause with a diagnostic table, separate...
Requalification, Troubleshooting and Retrofit o...
§4.32 sets the minimum content and maximum intervals of requalification, but the frequency must be justified. How to read alarms and trends, isolate root cause with a diagnostic table, separate...
URS for Cleanrooms and HVAC Systems: Requiremen...
An ambiguous URS requirement becomes a qualification deviation. This article shows how to structure a cleanroom and HVAC URS, where each number legitimately comes from, and how to rewrite wording...
URS for Cleanrooms and HVAC Systems: Requiremen...
An ambiguous URS requirement becomes a qualification deviation. This article shows how to structure a cleanroom and HVAC URS, where each number legitimately comes from, and how to rewrite wording...
