Packaging testing of pharmaceutical products

Testing of materials acc. European Pharmacopeia (Ph.Eur)

Testing of Polyolefins, PVC, PET, Rubber under GMP

• Appearance of solution, Absorbance, Identification A, B, C
• Acidity and alkalinity
• Appearance of a solution
• Extractable metals
• Heavy metals
• Sulfated ash;
• Plastic additives,
• Reducing Substances
• Phenolic and non-phenolic antioxidants,
• Amides and stearates
• Penetrability

Testing is conducted according to method described in the current edition of Ph.Eur. Monographs:

(3.1.3) Polyolefins

(3.1.4) Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparation

(3.1.5) Polyethylene with Additives for Containers for Parenteral Preparations and for Ophthalmic Preparations

(3.1.6) Polypropylene for Containers and Closures for Parenteral Preparations and Ophthalmic Preparations

(3.1.15) Polyethylene Terephthalate for Containers for Preparations not for Parenteral Use

(3.2.9) Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders