B6.4. Physicochemical test results ........................................................................................................11
B6.4.1. Tests on plastic materials and components used to package
medical articles USP <661> ............................................................................................11
B6.4.2. Tests on plastic containers for aqueous solutions for parenteral infusion EP 3.2.2.1 ........11
B6.4.3. Tests on polyethylene with additives for containers for parenteral preparations and for
ophthalmic preparations EP 3.1.5 ....................................................................................11
B6.5. Functional testing ........................................................................................................................11
B6.5.1. Accelerated ageing ..........................................................................................................11
B6.5.1.1 Accelerated ageing tests on film properties........................................................11
B6.5.1.2 Accelerated ageing tests on weld properties......................................................13
B6.5.2. Sterilization validation ......................................................................................................14
B6.5.3. Freezing study..................................................................................................................14
C. Extractables and leachables data of the Allegro TK8 film......................................................................16
C1. Extractables study ................................................................................................................................17
C1.1. Introduction ................................................................................................................................17
C1.2. Study purpose ............................................................................................................................17
C1.3. Results of extractables study ......................................................................................................18
C2. Leachables studies................................................................................................................................19
C2.1. Introduction ................................................................................................................................19
C2.2. Study purpose ............................................................................................................................20
C2.3. Test methods ..............................................................................................................................20
C2.3.1. pH ..................................................................................................................................20
C2.3.2. Conductivity ....................................................................................................................20
C2.3.3. TOC ................................................................................................................................20
C2.3.4. Metals..............................................................................................................................21
C2.3.5. Volatile organic compounds via purge- and trap GC/MS ................................................21
C2.3.6. Semi-volatile organic compounds via dichloromethane extraction + GC/MS....................21
C2.3.7. Non-volatile organic compounds via dichloromethane extraction + LC/MS......................22
C2.4. Evolution of pH with time ............................................................................................................22
C2.5. Evolution of conductivity with time ..............................................................................................23
C2.6. Evolution of TOC with time ..........................................................................................................23
C2.7. Evolution of metals with time ......................................................................................................24
C2.8. Evolution of extracted components with time ..............................................................................24
C2.9. General conclusion of leachables studies ....................................................................................26
C2.10. Summary of results....................................................................................................................26
C2.11. Leachables study full results......................................................................................................33
C2.11.1. Test solution WFI ........................................................................................................33
C2.11.2. Test solution Ethanol 20% ..........................................................................................33
C2.11.3. Test solution HCl..........................................................................................................33
C2.11.4. Test solution NaOH......................................................................................................33
C2.11.5. Test solution NaCl........................................................................................................33
C2.11.6. Test solution DMSO 10% ............................................................................................33
C2.11.7. Test solution Tween 0.1% ............................................................................................33
www.pall.com/biopharm 3