Pharma Engineering Insights
Pharmaceutical Water Generation Technologies: R...
RO, EDI, ultrafiltration and distillation cannot be compared in the abstract: the choice depends on source water, biofilm control, sanitisability and qualification effort. Criteria, regulatory constraints and a decision matrix...
Pharmaceutical Water Generation Technologies: R...
RO, EDI, ultrafiltration and distillation cannot be compared in the abstract: the choice depends on source water, biofilm control, sanitisability and qualification effort. Criteria, regulatory constraints and a decision matrix...
Centralised, standalone or hybrid EMS: how to c...
Centralised, standalone, portable or hybrid: how to choose the architecture of a GMP Environmental Monitoring System starting from intended use, with a decision tree, a weighted comparison matrix and criteria...
Centralised, standalone or hybrid EMS: how to c...
Centralised, standalone, portable or hybrid: how to choose the architecture of a GMP Environmental Monitoring System starting from intended use, with a decision tree, a weighted comparison matrix and criteria...
Dead Legs, Slopes, Materials and Hygienic Desig...
L/D ratio, slope, velocity and Ra are routinely presented as GMP requirements. They are not. How to separate what Annex 1 requires from what industry standards quantify, and how to...
Dead Legs, Slopes, Materials and Hygienic Desig...
L/D ratio, slope, velocity and Ra are routinely presented as GMP requirements. They are not. How to separate what Annex 1 requires from what industry standards quantify, and how to...
Environmental Monitoring Risk Assessment and Sa...
How to select and justify sampling locations for an environmental monitoring programme: a step-by-step risk-based method, use of qualification data and airflow studies, a sampling location justification matrix, worked reasoning...
Environmental Monitoring Risk Assessment and Sa...
How to select and justify sampling locations for an environmental monitoring programme: a step-by-step risk-based method, use of qualification data and airflow studies, a sampling location justification matrix, worked reasoning...
Quality Risk Management for Pharmaceutical Wate...
Many water system risk assessments describe the plant without deciding anything. Here is how to identify hazards and control points, use FMEA without abusing it, state residual risk honestly, and...
Quality Risk Management for Pharmaceutical Wate...
Many water system risk assessments describe the plant without deciding anything. Here is how to identify hazards and control points, use FMEA without abusing it, state residual risk honestly, and...
URS for a GMP Environmental Monitoring System: ...
How to build the URS for a GMP Environmental Monitoring System: defining intended use and system boundary, writing verifiable rather than prescriptive requirements, and mapping each requirement to its rationale...
URS for a GMP Environmental Monitoring System: ...
How to build the URS for a GMP Environmental Monitoring System: defining intended use and system boundary, writing verifiable rather than prescriptive requirements, and mapping each requirement to its rationale...
