1. Introduction
The traceability of components, assembly processes and associated records used in the manufacture of pharmaceutical grade products is a fundamental requirement of quality management systems such as ISO 9001 and principles defined within cGMP guidelines and associated European Directives and FDA Regulations 21CFR 210 & 211. domnick hunter is certified to ISO 9001 and manufactures according to the principles above.
2. Product Identification
To enable full traceability, cartridge and capsule filters are identified by two traceable numbers;
- a lot number etched on the end cap
- a serial number stamped on the outer sleeve of the filter cartridge, or etched on the capsule end cap.
The filters are manufactured in two defined stages:
Stage 1 - Module Manufacture
Membranes, medias and supports are batched and pleated into a ‘pack’ module. It is during this stage that the filter cartridge receives a unique serial number.
Stage 2 - Cartridge/Capsule Manufacture
Module packs, end caps and ‘O’ rings are batched and assembled into a finished cartridge/ capsule. Where appropriate, the finished cartridge is flushed and integrity tested before drying and final packing. During batching of components, a lot number is etched onto the end cap of the filter cartridge/ capsule.
i) Stage 1 - Module Manufacture
The serial number stamped into the sleeve of the filter can be traced to a Module Routing Sheet (MRS). The MRS details all manufacturing data for the module throughout each of the process phases. The MRS also lists the membrane and support media used in the construction of the module, including batch number and roll number.
Module Routing Sheet Pt1Click on image to view large
Module Routing Sheet Pt2Click on image to view large
ii) Stage 2 - Cartridge/Capsule Manufacture
Each batch of filters is manufactured using a traceable Lot Number. The Cartridge Routing Sheet (CRS) details all manufacturing data for the filter cartridges/ capsules, throughout each of the process phases, and includes a list of the module serial numbers used in the manufactured Lot. It is possible to trace manufacturing history from either a Lot Number or a Serial Number. However, to identify individual integrity test data for a finished cartridge/capsule, the Serial Number must be supplied.
Cartridge Routing SheetClick on image to view large
Pressure Decay and Aerosol Challenge Test RecordClick on image to view large
3. Technical Support Group activities
domnick hunter have a trained team of scientists and engineers available to answer questions regarding the technical capabilities of our products, to assist in the selection and design of appropriate filtration systems and to provide user training programs. The following services can be delivered both on site and in-house;
- filterability testing to optimise filter system design
- advice on the development of integrity testing, steam sterilisation and clean in place procedures
- development of validation procedures
- troubleshooting
- facility audits to ensure continued optimisation of filter use
- operator training including filtration theory, filter system design and management, validation, etc.
For more information on any of the above support services please contact your local domnick hunter representative. email: tsg@domnickhunter.com
