Rommelag Pharma Service

The Rommelag Pharma Service offers customers who purchase its world-leading bottelpack® systems an effective, economical, and widely accepted holistic scheme for extracting the best results from Blow-Fill- Seal (BFS) technology.

In addition, the service offers expert qualification, validation and consulting for clients in the pharmaceutical industry.

Service scope

The service is leveraged from Rommelag’s advanced Knowledge of Blow-Fill-Seal (BFS) technology and can be applied additionally to both upstream and downstream Installation and Infrastructure.

The Rommelag Pharma Service provides a key resource for clients looking to establish cGMP production lines using bottelpack installations.

The Service can call on unrivalled expertise from Rommelag as the inventor and pioneer of BFS Technology and with long established experience of GMP standard production in its own CMO business. This is particularly important in exploiting the core advantages of BFS filling, a highly innovative technology in which blowing of the container, filling of the product and sealing of the container can be performed in one operation cycle.

Service features

The Rommelag Pharma Service includes a number of deliverables:

Preparation and Execution of Qualification Documents: This can include User Requirement Specification URS,: Risk Analysis, Design Qualification (DQ), Installation Qualification (IQ,) Operational Qualification (OQ) and Performance Qualification (PQ).

Consulting: Rommelag can provide detailed advice on auditing of production layout, facility design, BFS installation, Upstream and Downstream Installation

Training: The Rommelag Pharma Service can offer expert training in the specialist skills needed for BFS production and other BFS related tasks.

Qualification and validation: Rommelag Pharma Service offers bottelpack system users a quick and economical complete route to fully compliant qualification and validation. The service is designed to assist QA, QC, Production and Engineering professionals in setting up, qualifying and validating machines to GMP standard, to comply with regulatory stands including EU-GMP, FDA, CFDA, WHO, PIC S, ICH, ANVISA and ISO 13485.

The service is equally applicable to newly purchased systems or those already installed and operational.

Resources

Click on Validation to learn more about service features.