Full-scale Processing for Clarification


Once the process of scale-up is completed and commercial production has started, what can help you to ensure smooth operation in the years ahead? The following services and expertise can help you meet this goal:

Operator Training
Ensure that your operators and equipment are functioning exactly as planned.

Integrity Testing (applicable to TTF membranes only)
Consider the support available to address any performance issues which may arise during the use of the product. Are procedures in place to complete post-use evaluations? Does the product come pre-use integrity tested or are there procedures to complete pre- and post-use integrity testing (if applicable)?

Post-approval Changes
While it’s preferable for both customer and supplier that no raw material or product changes occur over the life cycle of a filtration product, changes can and do occur. Make sure that you are aware of notification policies and the availability of Quality Audits. Notifications of change and Quality Audits are two ways you can navigate the hurdles of post-approval change.

Change Notifications
Because changes in a supplier’s product can require re-validation of your manufacturing process, you need stable process materials. When regulation changes, customer needs, or other factors require that a product is modified, make sure change notification process provides you with:
  • Detailed information so that you can judge revalidation requirements
  • Documentation change support
  • Advance notice of changes affecting product form, fit, or function so you can accurately determine the impact of these changes on your processes
Quality Audits
To ensure our quality systems operate as designed, we perform self audits. These audits provide us with ongoing internal communications that lead to manufacturing process improvements. In addition, Merck is routinely audited by external agencies such as the U.S. Food and Drug Administration (FDA) for compliance with the Medical Device GMP regulations, and internationally accredited registrars for compliance with the ISO® 9000 Quality Systems Standards. Customers are welcome to visit or audit our worldwide manufacturing facilities to observe our Quality Management System in operation.

Technology Transfer
Moving your production to a new facility? Can your supplier help you make that migration quickly and efficiently, while minimizing expense? Is there an experienced technical staff of scientists and engineers to help you resolve issues as they arise?

These are questions that need to be addressed in your technology transfer plan well in advance of the actual transfer.

Products and Services

Merck offers a full line of clarification products and services to help speed your biotech and plasma-derived products to market faster and more cost effectively.

Millistak+® Pod Disposable Depth Filter System
Innovative, high-performance Pods are ideal for primary and secondary clarification in lab, pilot, and process-scale applications.

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