QA/Standards

Quality is Mobilak’s supreme goal. Mobilak applies all necessary efforts to achieve a consistent quality control process.

Mobilak Ltd. is ISO 9001-2015, and ISO 15378-2015 (GMP) certified by the Standard Institution of Israel.

The Clean Pack Pharmaceutical bottles are listed with the FDA under DMF #032231 and manufactured in accordance with GMP requirements.

All raw materials used in the process of manufacturing Pharmaceutical Plastic Bottles are approved for direct contact with food according to CFR 21 and by European Union Regulations.

All raw materials are tested and confirmed according to USP 661.2 regulations.

All raw materials have DMF and are approved for the use in Pharmaceutical Bottles.

Mobilak’s Pharmaceutical Plastic Bottles are produced and packaged in

ISO 8 (Class 100,000) clean room.

Mobilak’s Pharmaceutical Plastic Bottles are tested and confirmed to USP 661.2 regulations.

Mobilak’s uses a world class Injection Blow Molding Machine to produce

Pharmaceutical Plastic Bottles.

Mobilak uses an oil free air compressor that prevents any air contamination.

Mobilak’s Pharmaceutical Plastic Bottles are packaged in clean PE bags that are manufactured in ISO 8 (class 100,000) clean room as well.

Mobilak’s quality assurance system is certified with the Standard Institution of Israel for ISO 9001 – 2015.

Production of Mobilak’s Pharmaceutical Plastic Bottles occurs under GMP conditions according to ISO 15378 – Primary packaging materials for medicinal products. This includes the infrastructure and the production process.

Mobilak’s Pharmaceutical Plastic Bottles are meticulously tested and inspected with the highest standards in mind.