Troubleshooting Production

Troubleshooting tablets considered as Out-of-Specification

We Find Individual Solutions for Your Samples

We are experts of pharmaceutical technology, and we know how to combine knowledge of substances and formulation with insights into processes and technology. In many cases, issues arising in production are a combination of both sides. Problems, for example tablet defects as capping, laminating, oos or sticking, can occur not only in context of a change or innovation within the manufacturing procedure but also suddenly and against expectation. Please, give us a call! We can help you with troubleshooting tablets that are e.g. considered as Out-of-Specification — fast and without red tape.

 

Difficulties in Production Such as Out-Of-Specification: We'll Find the Solution

In troubleshooting, there is no standard solution – not for tablet capping, laminating, sticking, or Out-of-Specification. Every difficulty is individual and requires a customized approach to solution. Only then a smooth production in pharma can be guaranteed.

During a free initial consultation, we can discuss your situation and try to narrow down the problem of tablet defects. As the case may be, we can give you some ideas how the problem could be solved. We can easily arrange an appointment for an initial consultation, or you just give us a call.

 

Discreet and on Short Notice – In That Way We Help You in Your Production

Naturally, we observe silence about any content discussed. For an initial consultation, we usually don‘t need to know precise names of API or product. They can remain anonymous. To explore the source of the difficulty we might want to know certain product properties. We do not see the need for a confidential disclosure agreement at this point. This way, we are ready to start right away. However, if you prefer, we can sign a CDA beforehand. schnell und unbürokratisch loslegen. Natürlich sind wir aber auch bereit ein CDA abzuschließen.

Depending on the urgency and the problems‘ nature we can also arrange to come to your site on short notice. Most production challenges can be solved best with troubleshooting tablets on-site. Sometimes, minor details in handling can already make all the difference.

Troubleshooting in tableting

If time is not as crucial, we will design an approach to resolve the problem after our first consultation. In many cases, we will contact you with some more queries. The extraordinary challenge with production issues is that the solution has to be found within very tight limits. Major changes must be authorized We prefer to spare you this effort and the high cost involved. We will discuss the proposal for solution with you and answer your requests directly.

 

We Find Individual Solutions That Help You Quickly

In some cases, it makes sense to conduct some preliminary trials in our lab. Such pretrials allow us to better analyze the cause of any issues and tablet defects. Key advantages of troubleshooting are:

  • Less material for pretrials
  • No blocking of production capacities
  • No batches Out-of-Specification

Findings from pretrials to avoid defects of tablets or Out-of-Specification can then be adapted to your production. Of course, we assist in monitoring this transfer to your site. There are also cases where pretrials have no benefits. Then we favor finding a solution together and directly on-site. The purpose of all approaches is to ultimately develop a solid solution for the long-term —despite the generally serious time pressure.

Of course, we document all trials and stages of troubleshooting tablets for you and can write a comprehensive report if you wish for it.

We are ready if you need our help with production problems such as production outage, blocked batches, or Warning letter. Together we‘ll find solutions for seemingly insoluble problems.

Just contact us!

Tablet production