Full-scale Processing
for Virus Safety


Step 7

Maintaining product purity and operational productivity as you ramp to full scale production is a significant challenge. Errors can and do occur, some resulting in costly lost batches. When problems occur, we can help you:

Operator Training

Viresolve® Operator and Instrument Qualification program – Ensure that your operator and equipment are functioning exactly as planned.

Manage integrity test issues

Our filters feature non-destructive integrity testing. In the rare event, that a Merck device performs in a sub-optimal manner, our staff can quickly and accurately retest and offer technical advice 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:
Merck's ultimate goal is to provide products and services that satisfy our customers' needs. To ensure our quality systems are operating as designed, we perform self audits. These audits provide us with ongoing internal communications that lead to improvements in our manufacturing processes.

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.

Lastly, you, the customer, 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.

Learn more about our new products and services using the links below:
Want to talk? Contact the Viresolve® Team.
  • Viresolve® Pro Solution – A next generation parvovirus safety solution designed to provide the highest levels of retention assurance and productivity.

  • Provantage® Services – We offer a range of services that enable you to leverage Merck’s 50 years of experience providing unmatched application, validation and engineering expertise to researchers and scientists around the globe.

  • Full Scale Processing – It is easy to install the new Viresolve® Pro filters in a Viresolve® Pro Magnus Holder with an ergonomically designed flow path with a small footprint, ideal for limited manufacturing space.

    View the Viresolve® Pro+ Magnus Holder Interactive Guide

  • Integrity Testing – Learn more about Merck's Binary Gas Test and how this innovative and highly sensitive integrity test provides the highest level of virus retention assurance.

    Watch the Binary Gas Test Video 

 
 
Webinar: Parvovirus Retentive Filter Spiking Study Best Practices - Watch Now

Webinar:
Parvovirus Retentive Filter Spiking Study Best Practices

Watch Now
Viresolve® Pro+ Magnus Holder Interactive Guide

Viresolve® Pro+
Magnus Holder
Interactive guide

Learn More