CROSS-CONTAMINATION CROSS-CONTAMINATION

Dr. Muslim Suardi, MSi., Apt. Dr. Muslim Suardi, MSi., Apt. Faculty of Pharmacy University of AndalasFaculty of Pharmacy University of Andalas

Arises from: Arises from:

Uncontrolled release of Uncontrolled release of dust, gases, vapors, sprays or dust, gases, vapors, sprays or organisms from materials & organisms from materials & products in processproducts in process

Residues in equipmentResidues in equipment

OperatorsOperators

Most Hazardous:Most Hazardous:

Potent low-dose materials Potent low-dose materials Sensitizing agents Sensitizing agents Cytotoxic materials Cytotoxic materials Some living organismSome living organism

Minimizing of Cross-Minimizing of Cross-ContaminationContamination

* Facilities * Facilities * Procedures* Procedures* Air-flow rates & directions * Air-flow rates & directions

Controll Cross-ContControll Cross-Cont11

* Processing & filling in segregate area* Processing & filling in segregate area

* Avoiding manufacture of different * Avoiding manufacture of different products at the same time products at the same time

* Containment of material-transfer by * Containment of material-transfer by means of air-locks, air extraction, means of air-locks, air extraction,

clothing change, & careful clothing change, & careful washing & decontamination of washing & decontamination of

equipment equipment

Controll Cross-ContControll Cross-Cont

Re-circulation of untreated air, or by inadvertent re-entry of extracted air

Use closed systems

Common source of cross-contamination:

“Ineffective cleaning of equipment“

Attention !!Attention !!Cleaning of: Cleaning of:

Pipelines Valves Joints Bearings Blanked-off ends Drying Milling Sieving Blending Equipment

Protective clothing worn Protective clothing worn

* Should not be worn out side* Should not be worn out side it Should be laundered in it Should be laundered in such a place & manner that such a place & manner that contamination is contained contamination is contained

One product only at a timeOne product only at a time

* Ovens * Other equipment

PROCEDURESPROCEDURES

Should especially be established for

monitoring likely contamination by:

* Potent low-dose

* Sensitizing agents