GLE offers a complete design, procurement, installation services for sterile processing and packaging equipment.

GLE services are totally flexible to the project needs of a Client. GLE can provide the necessary support, whether the Client requires the preparation of a User Requirements Specification (URS) for a single item of equipment or total project & documentation management for a fully integrated sterile filling and lyophilization system.

Essential to the execution of all the services offered by GLE is the extensive hands on experience of the GLE engineers with equipment and Vendors. This experience ensures efficiency by eliminating the “readily available subjective opinion” with respect to equipment performance and Vendor capabilities from the very first day of the project.

For all project types, GLE implements a standard project approach based on GAMP4 methodology. This project approach not only addresses the practical aspects of equipment design, construction and building integration but also fully integrates a defined validation and regulatory compliance strategy from preparation of the first equipment concept layout to the hand over of the completed equipment to production.

As a part of the GAMP4 methodology GLE places great emphasis on the quality and traceability of Client and Vendor documentation, especially the User Requirements Specifications (URS), Procurement Specifications, Functional Requirements Specifications (FRS), Software Design Specifications (SDS), Hardware Design Specifications (HDS) and the Mechanical Design Specifications (MDS).

The key project phases supported by GLE are as follows:

Process Description Preparation
Validation Master Planning
21 CFR Pt.11 Strategy Definition
Equipment Budgetary Pricing (±20% & ±10%)
URS Preparation
Equipment Procurement Specifications Preparation
Procurement Assistance
Equipment Construction Management
Vendor Documentation Reviews
FAT Protocol Preparation
FAT Planning & Execution
Installation Supervision
Commissioning Supervision
Training Management
SAT Protocol Preparation
SAT Planning & Execution
Engineering Turnover Packages
Validation Assistance (IQ, OQ & PQ)