Pharmaceuticals and Medical Devices

/Pharmaceuticals and Medical Devices
Pharmaceuticals and Medical Devices 2018-01-17T18:05:04+00:00

Pharmaceuticals and Medical Devices

Aminolab is the leading company for analytical laboratory services in Israel. Its state-of-the-art
laboratories provide its customers with reliable support and professional expertise in a wide
variety of analytical fields – all under one roof.

Aminolab also provides services in these fields:

Water • Food • Cosmetics • Environment (sewage, soil, air)

The Pharmaceuticals and Medical Devices field is characterized by constant innovation, in both the quality and variety of its products.

Regulations in this field are very strict, constantly updated and high quality demanding. Proper handling of sterile supplies and regular checks of their expiration dates help prevent infections and ensure patients’ safety— with special emphasis on the microbiological conditions of the products.

Aminolab is known for its quality and professionalism. The laboratory is a leader in implementing new technologies in accordance with customers’ needs and regulatory requirements.

The Microbiology Laboratory, which carries out most of the tests related to pharmaceuticals and medical devices, is accredited and complies with GLP standards. It is supervised by the Israel Laboratory Accreditation Authority and in accordance with EU protocol EEC/88/320. The Microbiology laboratory is also recognized by both the Israel’s Ministry of Health and the FDA for meeting and complying with cGMP standards. This accreditation includes non-sterile and sterile products testing, package integrity and shelf-life studies of pharmaceuticals and medical devices. The company’s laboratories also serve as in-house laboratories for several companies and are a strategic provider of services to Israeli and international companies. During 2015 the Chemistry Laboratory was recognized by the Israeli Ministry of Health for complying with cGMP standards.

A partial list of the tests the laboratory performs:

Microbial limits testing (MLT) for non-sterile products

Sterilization validation (steam, EtO and radiation)

Antimicrobial effectiveness testing

Cleaning validation of medical devices

Shelf life of medical products, including inspection of packaging integrity (peel, dye, burst, leak test for vials)

Sterility testing

Metals by ICP-MS

Endotoxins Test

ETO residues by GC-FID

Bioburden test