Preventing API waste with a GMP-adapted micro dosing system. It worked with combined forces. An economical and safe solution, also for your process! Completely validated according to GMP.
A major player in the pharmaceutical industry had long been familiar with the application of the highly accurate and pulsation-free micropumps of HNP Mikrosysteme on a laboratory scale. Over time, increasingly more far-reaching questions and requirements were asked. For the very accurate dosing of 2 products, 2 microdosing systems were ultimately requested in accordance with GMP. However, the systems of HNPM are not standardized on GMP.
HNPM MoDos micro dosing system. GMP compliant.
GMP (Good Manufacturing Practices)
In order to comply with GMP quite a few demands are made. Both on the materials used and the roughness of the surface and with regard to the cleanability of the dosing system. Because contamination is undesirable and even not allowed. The ultimate goal of GMP is to always guarantee the same high quality product, without the risk of cross-contamination by residual product in one of the components of the process equipment.
GMP provides a number of procedures and guidelines. The purpose of the procedures is to make each component traceable. All batches must be validated. This means that they are recorded with certificates. For laboratories, this means that DIN is used as a guideline. This is a European guideline. This also immediately complies with CE.
Only a carefully recorded and controlled production process ensures the quality of a medicine.
The standard microdosing systems of HNPM do not meet GMP. To achieve this, adjustments had to be made.
Our solution
To prevent material from remaining in the dosing system and unnecessary API usage, the standard system has been modified on several fronts. A special flow meter that meets GMP was also selected.
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Surface roughness
The standard material roughness of HNPM micro pumps is Ra 0.8 µm. The customer requested a surface roughness of only 0.5 µm. This roughness is not possible everywhere. In the present case, a surface roughness of Ra≤0.8 was feasible for both filter and pump.
HNMP micro pump type mzr-6355
A Ra 0.8 is actually already very exceptional and was more than sufficient for a GMP application. They also agreed to a roughness of 0.8 µm. The best (smoothest) we could deliver at that time.
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New type of filter developed with small internal volume (7ml)
HNPM developed a new type of filter, the FM10, with a smaller internal volume compared to other standard filters from HNPM (FM12 = 36ml, FM10 = 7ml). The Ra of the filter was just like that for the pump 0.8 µm. The advantage of this new filter is that it can be cleaned easily. Both CIP and SIP!
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Adjusting NPT connections (fittings)
The NPT fittings have been modified to fittings without corners and dead volume, making them easy to clean and sterilize.
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PEEK tubing with an internal diameter of only 1.8mm!
A type of tubing with a smaller internal diameter was used.
The original tubing: Internal diameter 4.0mm, external diameter 6mm.
The new tubing: Internal diameter 1.8mm, external diameter 2mm.
The advantage of this is that less API needs to be used (less API waste!).
In addition, this provides an improved volume flow and ensures faster and more efficient flushing.
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Documentation
Inspection documentation was made available for the wetted parts:
- Pump/filter/flow meter
- Tubing/connections/adapters/seals
- Snakes
For the metal products, 3.1 certificates and the Declaration of compliance 2.1 (DIN EN 10204:2005) have been supplied.
In summary
- The system has a perfect surface roughness of Ra 0.8 µm
- FDA approved materials are used
- All necessary certificates are available
- CIP and SIP cleanable
- Precise and pulsation-free flow, independent of differential pressure and volume flow!
With the implemented adjustments and documentation, the dosing system now perfectly complies with GMP!
An economical and safe solution, also for your process! Completely validated according to GMP.