Select online liquid measuring equipment for the pharmaceutical process when the six important matters to consider

systemMedicine industry is one of the heavily regulated industries involved in pharmacovigilance, in short, must always pay attention to safety, quality and effectiveness.From the development of new drugs, in the whole process of production until it provides to the customer are under more than 11500 strict regulatory restrictions, which measuring equipment put forward corresponding requirements for the pharmaceutical industry.

One of the regulator is the United States food and drug administration (FDA).It created the process analysis technique (PAT) framework, primarily for pharmaceutical innovation and modernization.Timely measurement data (using the available process related information online analysis tools)Support from mass production to continuous production (CM).Based on scientific, strict regulation, geared to the needs of mass production of the pharmaceutical industry, modern can reduce the cost of development, manufacturing and commercial.At the same time, the modernization can also help to ensure the product quality, reduce the batch difference.It by no longer limited to measuring the final product quality, also can help stabilize the products quality.

1. Online measurement

There are three kinds of process measuring equipment: online, along with the line and line.

Online (In - line) measuring device for measuring concentrations (no delay), will be immediately instructed the change of process conditions without consuming material can be measured.They are also from the process conditions of actual measurement, no dilution or change, and is likely to dilute or change in the process of sampling density.Real-time measurement allows for continuous processing, which will improve the production efficiency and profitability, to ensure the stability of the final product quality, reduce waste and production at the same time the lockout.

With line (On - line), installation of equipment from the head of measure way to extract a sample, after measure the sample back to the head of road or abandoned.Nearly line (the At - line) process analyzer from technological process to extract the sample, then send it to separate analyzer for testing.

2Record the.

In the pharmaceutical industry, the record is essential link in quality assurance and control system.The whole appraisal process also record must be complete.

Measuring equipment installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocol records confirm order, delivery and installation of the correct process equipment models and parts.It also ensures that equipment meet the performance specifications, can use the selected measurement method is a typical sample measured in a reliable way.If the supplier does not provide qualified record information, the buyer complete equipment appraisal process can be very time-consuming.

3. The electronic data capture and storage

For pharmaceutical companies, only is not enough to record the production information in digital way.Data security problem also nots allow to ignore.So you need to only authorized personnel can access measurement system, also need to be equipped with a record of these activities of the system.

4. The ductility

All drugs are development and preparation in the laboratory.After production, on the basis of batch production gradually increased, until you reach a commercial scale.For example, including the simulation of the full scale production pilot plant to produce enough products to clinical trials and commercial production.

Choose the appropriate measuring equipment is crucial, so that companies can work with the end-to-end, from r&d to test again to full scale production.Otherwise, the early stage of testing and the results may not represent the process scale design, lead to delay in production.Measurement goal is continuous monitoring of full scale production process.

5. The pharmaceutical grade liquid material

Contact with drugs of any equipment in the production process must be approved for operation of their specific conditions, must conform to the physical contact with the drug material compatibility.Conform to the hygienic design of measuring equipment can be resistant to chemical and process cleaning procedures, to ensure the measuring equipment will not be dangerous or pollutants into the process.

Suitable for pharmaceutical process measurement equipment has the following features:

• A certified health contact material, such as stainless steel 316 l
• Biological compatibility standard gasket material (according to the USP class VI electrolytic polishing product contact surface finish)
• Product surface roughness Ra 0.38 microns or biggest 15 inches
• Do not use the ingredients of animal origin in processing or machining (ADI)
• Accord with standard of clean CIP and SIP

6. The NIST the traceability of the calibration and accuracy, and instrument test

In accordance with regulatory requirements, all automated mechanical and electrical measuring equipment must be according to the design used in written quality plan to ensure normal production performance for calibration and checking.

The traceability of the measuring instrument used for traceability on current international definition, measurement results can provide assurance that could satisfy the requirement of accuracy of regulators - for example, the national institute of standards and technology (NIST) to establish the standard.NIST traceable calibration is an assurance plan, used for certification of a manufacturer is fully capable of in accordance with the (NIST) standard calibration equipment, and the manufacturers to provide all products meet the measurement standards promulgated by the NIST.

The validation process to ensure normal operation of equipment in accordance with the relevant provisions of regulations.By international standards with the instrument calibration verification (e.g., NIST) associated to get effective result, but also ensure the traceability.In addition, the accuracy of measuring equipment calibration and traceability should be simple, user-friendly site operation.

Visa K - drug PATENTS refractometer

Visa, K - drug PATENTS refractometer PR - 43 - PCIs a kind of useThe refractive index measurement technologyOnline instrument, support for drug development and production as well as the biological technology processing procedure.

This refractometer can be used in:

• Process evaluation, verification and troubleshooting.
• Collecting data, through different experiments and operation process.
• Looking for process model.This is during the scale of reference, to confirm process according to the design requirements, to ensure that the process of equivalent.
• Monitor the performance of the pilot and full scale production, in addition to monitoring the solvent, the concentration and purity of raw materials and finished products.
• Monitoring of mixed operation, get the right ratio of the reactants.It can track the reaction degree, the different solvents and process adaptability.
• Determine a saturation point in the process of crystallization.

Refractometer, moreover, the data can be sent to the control system (DCS) to develop the automatic control strategy to make the process standardization and guarantee consistent quality, prevent the batch difference, reduce the production time and cost, increase production and ensure product safety.

Online measuring the refractive index can help during the scale immediately identify problems and shorten the development time.Please visit our page of the pharmaceutical industry, and understand allThe refractive index measurement applications.

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