Representative for sterile lyophilization production products
Founded in 1991, the company provides customized solutions to ensure compliance, adherence to regulation, safety and efficiency. It specializes in a full range of services from defining customer needs, to providing solutions and long term support.
representatives of Teclen gmbh in Israel,
Lab equipment for lyophilization of active pharmaceutical ingredients.
Sole representatives of IMA Life in Israel for Freeze-Drying equipment, since January, 2005 (Former Edwards Freeze Drying Solutions)
Areas of Practice
CALIBRATION AND VALIDATION
Conducting scheduled calibration, validation testing and producing protocols and reports:
Calibration:
Vacuum/ Pressure
Temperature
…more
Validation
IQ/ OQ/ PQ protocols writing
Validation Testing
Protocols/Reports Review and QA approval
FREEZE DRYING TECHNOLOGY
Meeting customer needs from conception to completion and ongoing, long-term support:
URS
FAT
SAT
Validation Protocols
Long-term Maintenance:
Calibration
Re-qualification
REGULATORY DOCUMENTATION
Producing regulatory documentation as per cGMP/ GLP requirements:
IQ/ OQ/ PQ Protocols
SOPs
Risk Assessment Documentation
Instrument Files
Engineering Documentation
INDUSTRY REGULATION INSIGHT
Arie Elster Engineering had been involved in the pharmaceutical community for over 25 years.
Determining the customer regulatory needs from sterile production, aseptic processes’ to R&D.
Conducting Education and Training Seminars for Pharmaceutical Industry
Let's Chat
Use the form below to contact us regarding the needs of your company.
For job opportunities, please email us your resume. We’re always looking for new and exceptional talent to join our team.
☎ CONTACT
Tel: +972-9-7672474
Mobile: +972-52-3217508
Email:
info@elstereng.co.il
Fax: +972-9-7660547
➤ LOCATION
2 Ha’Eshel St. Suite 13
Kfar-Saba 4423502
Israel