Case Studies

Upgrade of filling machine including RABS installation and transition from piston to peristaltic pump technology. Process robustness assessment for two suites.

End-to-end procurement support — URS writing, vendor evaluation, technical and commercial comparison, and selection of the optimal powder filling system.

Technical support for sterile homogenizers and compounding tanks. Process design for complex sterile products. Industry seminar delivery.

Introduction to isolator technology and VHP sterilization for an early-stage biotech startup. VHP cycle development and optimization.

Resolved critical issues in filling of oxygen-sensitive product. Technical and scientific support for freezing of vial-filled product.

Design and construction of a unique stoppers feeder mechanism for an existing filling machine — solving a production bottleneck without full line replacement.

Shamir Optical — comprehensive assessment and final report of damage to machines and facility following a fire incident. Insurance and recovery support.

Comprehensive support in preparing a cosmetics company for FDA inspection — gap analysis, documentation review, and remediation guidance.

Assessment of materials and construction of an inspection unit for Grade A environment — ensuring equipment manufacturer's compliance with pharma requirements.

Improvements in maintenance module for Dot Compliance QMS. Implementation of the quality management system at a pharmaceutical client site.

Ravona — technical and knowhow support for the manufacturing of equipment for sterile facilities. Expert guidance on design requirements for aseptic environments.