Full-scale Processing for Ultrafiltration
As you ramp to full-scale production, it can be a challenge to maintain product purity and operational productivity. Errors can and do occur, sometimes resulting in costly lost batches. When problems arise, we can help you to:
- Train Operators
Ensure that your operator and equipment are functioning exactly as planned.
- Manage Integrity Test Issues
Our staff can quickly and accurately perform tests at your facility, as well as troubleshoot to resolve any issues.
- Manage Post-approval Changes
We work with our vendors to ensure supply continuity for as long as is practical. However, product changes can and do occur. Notifications of Change and Quality Audits are two ways that Merck helps you navigate the hurdles of post-approval change:
- Notifications of Change
Because changes in a supplier's product can require re-validation of your manufacturing process, we know you need stable process materials. When evolving customer needs, changing regulations or other factors require that Merck modify its products, our change notifications provide you with:
- Detailed information so that you can judge revalidation requirements
- Documentation change support
- Advance notice when changes affecting product form, fit, or function so that you can properly determine the impact 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 to the Medical Device GMP regulations, and internationally accredited registrars for compliance to 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? Merck can help you make that migration quickly, while minimizing expense. Let Merck’s experienced technical staff of scientists and engineers help you resolve issues as they arise. You can also leverage our collective experience and know-how to help you institute industry best practices.
Related Products and Services
Contact the Ultrafiltration Team to explore how we can help you avoid costly errors by verifying that your design falls within Merck’s guidelines (actual process performance to be verified with optimization and process simulation trials).