Consistency measurement of ointments and similar types of products in the pharmaceutical and cosmetic industry using the Penetrometer PNR 12.
One of the leading measurement methods used for quality monitoring in the pharmaceutical industry is consistency measurement by means of a penetrometer. Using this method, involving small sample quantities and short analysis times, precise statements can be made as to the quality of the measured sample. Subsequent decisions can then be made quickly and appropriate actions can be implemented.
It is characteristic for a penetrometer that a penetrator vertically pierces the sample in a freefall for a certain interval with a precisely-defined weight. The resulting penetration depth is a measurement for the consistency of the substance.
Ointments with a low consistency, for example, can be more thoroughly applied on the skin and more easily absorbed. On the other hand, a substance with a high consistency can be used to cover a wound effectively.
The method according to the European Pharmacopoeia 2.9.9. allows consistency measurements with a standard cone or a micro-cone.
In general, the measurement with the micro-cone is preferred based on the following advantages:
- Very small sample volume of 4 mL. This results in short temperature-stabilization intervals. Ideal in case of a limited sample volume in the development phase of new products.
- Broad range of application, from viscous liquids to hard pastes.
- Thanks to the separated sample cup, it is easy to fill without air bubbles.
How precise are these measurement devices, and how suitable are they for high-precision measurements? How can new devices be qualified for sophisticated measurements in the pharmaceutical industry, and to what extent are the necessary steps supported and shaped by the device manufacturer?
Use of the measuring devices from Day One: Anton Paar supports the qualification of devices for the pharmaceutical industry!
Whether it involves the testing of raw materials, intermediates or final products, complete quality supervision and precise traceability of measurements are of utmost importance, especially for pharmaceutical products. Therefore a strong and reliable partnership between pharmaceutical companies and the manufacturers of measurement devices is indispensable. This partnership, successfully achieved with devices of the Anton Paar group, is additionally supported in the form of a tailored qualification documentation (PQP-S, Pharma Qualification Package – Smart PNR 12), based on the so-called “6Q” model.
The “2Q” and “6Q” Model
Whereas the “2Q” model tests and documents the installation qualification (IQ) and operational qualification (OQ) of a newly-implemented device, the “6Q” model of the Pharma Qualification Package – Smart PNR 12, with the additional Qualification Instruction, the Design Qualification (DQ), the Performance Qualification (PQ) and the Final Qualification (FQ), represents the entire qualification required in the pharmaceutical industry.
QI – Qualification Instruction
The Qualification Instruction describes the complete procedure of every single qualification step in detail. The involved personnel and qualified accessories will be specified and documented.
DQ – Design Qualification
The Design Qualification of the Pharma Qualification Package – Smart PNR 12 comprises a qualification timeline and a risk analysis.
IQ – Installation Qualification
Based on precisely defined tests, the Installation Qualification ensures that the delivery and installation conform with the requirements of the supplier. It is the basis for reliable operation.
OQ – Operational Qualification
The Operational Qualification guarantees that the device fulfills the required specifications.
It comprises the following testpoints:
- Measurement of standards
- Operator training as well as a user SOP (standard operating procedure)
PQ – Performance Qualification
The Performance Qualification ensures that the device performs impeccably under routine conditions within the defined specifications.
FQ – Final Qualification
The Final Qualification of the Pharma Qualification Package – Smart PNR 12 comprises a deviation list and the final report summarizing the qualification of this instrument.
The Anton Paar “Pharma Qualification Package – Smart PNR 12”
As would be expected, qualification of a measuring device for the pharmaceutical industry involves a large time commitment, in combination with competent manpower, and thus represents a significant cost factor. Anton Paar has developed a “Pharma Qualification Package” for initial- and re-qualifications ehich gives optimal assistance towards achieving and maintaining the qualification status of the devices.
The Pharma Qualification Package – Smart PNR 12 fulfills the relevant pharmaceutical regulations Good Manufacturing Practice (GMP), Good Automated Manufacturing Practice (GAMP 5), and USP , and can be used to perform the qualification process in a significantly shorter time, yet at an equivalent level of diligence. This enables savings of valuable resources, above all time and money, during the implementation process. This “Pharma Qualification Package” represents the proper and recognized methodology for qualification of a device for use in the pharmaceutical industry.
Diligent quality monitoring, from raw materials and intermediates, right down to the final product
Pharmaceutical companies uphold a very high level of responsibility towards their patients. This explains the high standards that pharmaceutical companies place on their products with respect to quality and product safety. Quality and product safety are monitored with a suitable inventory of equipment, sometimes running 24/7.
Not only finished products are constantly tested for quality. Measurements are also performed on raw materials when they arrive, as well as during production routines, whereby considerable time pressure builds up as further processing of the product is often dependent on the result of the test measurement. This means that the measurement must be both extremely reliable and also quick, and only use small sample volumes, wherever necessary, as the samples are often expensive and only available in small quantities.
With these challenges, consistency measurement using the micro-cone method has proved to be extremely effective. With this simple rheological method, all requirements are fulfilled in one system: quickly, precisely and reliably.
In addition to inspection measurements on incoming goods and finished product declarations, knowledge concerning the consistency of a substance is important for many handling processes such as:
is extremely important. The energy balance of these processes is significantly determined by the optimization of the consistency parameters.
It becomes an all-too-familiar challenge when the quality inspection of incoming raw materials in the warehouse must be made immediately on-site. Raw materials, also in liquid form, need to be tested right away upon delivery, and production lines are examined in terms of their proper operational readiness. Due to the simplicity of the method and the easy operation of the penetrometer, the measurement can also be performed outside an analytical laboratory. The transportation of samples to the laboratory is no longer necessary. No specially trained experts are required to carry out the measurements since the routine can be learned very quickly supported by the intuitive menu navigation. Up to 16 different programs can be run independently by the user (password-protected if required).
Due to its superb reproducibility of < 3 %, the PNR 12 is also the ideal companion in quality monitoring, from raw materials, right down to the finished product. The threshold indication sounds an alarm when certain predetermined tolerances are exceeded. For a test series of up to 200 values, an integrated statistics function enables the calculation of the standard deviation, mean value, as well as max. and min. values. Connectivity to a LIMS system opens up all the opportunities of modern laboratory data management. As an alternative, the data can also be very easily read out using a USB stick.
The close collaboration between pharmaceutical companies and Anton Paar and the combination of the PNR 12 penetrometer with the “Pharma Qualification Package – Smart PNR 12” have made it possible to create quality monitoring conditions adapted to precise needs, guaranteeing utmost precision with a small sample quantity.