ACTIVITIES WITH CLIENTS

A phase III pharma  company

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Activity:

  • Supporting qualifications of new facility: Clean rooms, HVAC, WFI system, Autoclave, filling line, washing machine, facility BMS. Writing protocols, review and approval of protocols and qualification reports.

  • Writing quality and engineering policies and SOP’s

  • Writing maintenance instructions

  • Implementation of  QMS system (DOT Compliance)

  • Managing the process of locating a CMO for Fill & Finish of syringes.

A big pharma company

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Activity:

  • Technical support for sterile homogenizers and compounding tanks

  • Process design for complex sterile products

  • Seminar on the topic of sterile homogenization

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A phase III pharma  company

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Activity:

  • Support issues in filling of Oxygen sensitive product

  • Technical and scientific support for the freezing of a product filled in vials.

A big pharma company

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Activity:

  • Upgrade of filling machine including a RBAS and a change from piston to peristaltic pumps

  • Assessment of a filling room and ways for upgrade

  • Performing process robustness assessment for two filling suites

  • Support in filling room renovation

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A phase III pharma  company

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Activity:

  • Support the purchasing of powder filling machine (machine was ordered): Writing the URS, point of contact with vendors, technical and commercial evaluation of the proposals, comparison and selection of vendor.

  • Assessment of environmental monitoring requirements and selection of system for the purpose

A big pharma company

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Activity:

  • Building a unique stoppers feeder for a filling machine

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A big machine producer for the microelectronic and pharma companies.

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Activity:

  • Perform an assessment for the materials and construction of an inspection unit for grade ‘A” environment

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An early stage  start-up company

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Activity:

  • Introduction to isolators and VHP sterilization

  • Improvement of VHP cycle

Shamir Optical

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Activity:

  • Assessment and writing the final report of damage to machines and facility as a result of a fire.

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Cosmetics Company

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Activity:

  • Support in preparing the company for FDA inspection

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  • Improvements in new maintenance module

  • Implementation of the QMS in a pharma company

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Dot Compliance – Quality Management Systems

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  • Technical and knowhow support for the manufacturing of equipment for sterile facilities.

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Ravona – A manufacturer of isolators and protection glovebox