An important 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. In the course of time, people came up with more and more far-reaching questions and demands. For the very accurate dosing of 2 products, 2 micro dosing systems in accordance with GMP were eventually requested. But HNPM’s systems are not standardized on GMP.
GMP (Good Manufacturing Practices)
To comply with GMP, quite a few requirements are set. Both to the materials used and the roughness of the surface and to the cleanability of the dosing system. Because contamination is undesirable and not even allowed. The ultimate goal of GMP is to always guarantee the same high quality product, without risk of cross-contamination by residual product in one of the components of the process equipment.
GMP provides for several procedures and guidelines. The purpose of the procedures is to make each component traceable. All batches must be validated. This means that these are recorded with certificates. For laboratories, this means that DIN is used as a guideline. This is a European directive. This also immediately complies with CE.
Only a carefully recorded and controlled production process ensures the quality of a medicine.
HNPM‘s standard micro dosing systems do not comply with GMP. To achieve this, adjustments had to be made.
To prevent remaining material in the dosing system and not using an unnecessary amount of API, the standard system has been adapted on several fronts. A special flow meter was also selected that complies with GMP.
The standard material roughness of HNPM micropumps is Ra 0.8 μm. The customer asked for a surface roughness of only Ra 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.
A Ra 0.8 μm is actually quite exceptional and was more than sufficient for a GMP application. A roughness of 0.8 μm was therefore agreed. The best (smoothest) we could deliver at that time.
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 of HNPM (FM12 = 36ml, FM10 = 7ml). The Ra of the filter, like the one for the pump, was 0.8 μm. The advantage of this new filter is that it can be easily cleaned. Both CIP and SIP!
Adjustment NPT connections (fittings)
The NPT fittings have been adapted to fittings without corners and dead volume so that they can be easily cleaned and sterilized.
PEEK tubing with internal diameter of only 1.8mm!
A type of tubing was used with a smaller internal diameter.
The original tubing: Internal diameter 4mm, external diameter 6mm.
The new tubing: Internal diameter 1.8mm, external diameter 2mm.
The advantage of this is that less API must be used (less API waste!). In addition, this gives an improved volume flow and ensures faster and more efficient rinsing.
Inspection documentation was made available for the wetted parts:
- Pump/ filter/ flow meter
- Tubing/ connections/ adapters/ seals
For the metal products, 3.1 certificates and the Declaration of compliance 2.1 (DIN EN 10204:2005) have been delivered.
- The system has a perfect surface roughness of Ra 0.8 μm
- Use of FDA approved materials
- All necessary certificates are available
- CIP and SIP cleanable
- Accurate and pulsation-free flow, independent of differential pressure and volume flow!
With the adjustments and documentation made, the dosing system now perfectly complies with GMP!
An economical and safe solution, also for your process! Fully validated according to GMP.