CALIBRATION IN THE PHARMACEUTICAL INDUSTRY

INTRODUCTION

The purpose of calibration is to determine how accurate an instrument’s readings are, and then realign them to the instrument’s intended accuracy. For some manufacturers, drifting by a few number will not affect their overall product, however, in process manufacturing the accuracy of these instruments is crucial. Most process manufacturers have a regulatory body, such as the FDA, that needs to ensure all products are safe for consumption. Calibration helps to meet all regulatory standards.

For the pharmaceutical industry, calibration is an important step to meeting all standards. This white paper will cover everything about calibration in the pharmaceutical industry, from which instruments need to be regularly calibrated, to recognizing and choosing an accredited calibration lab.


CALIBRATION IN THE PHARMACEUTICAL INDUSTRY

The pharmaceutical industry operates under a lot of pressure. Any human error or adverse mistake could create consequences that effect millions of people. This is why the pharmaceutical industry is a highly regulated industry, following quality measures created by the Food and Drug Administration.

Over the last few years, the FDA has seen a spike in recalls among the pharmaceutical industry. These types of recalls can damage the reputation of a company. The proper calibration of instruments used in the production of pharmaceutical products can reduce recall numbers, saving the company from potentially dangerous recall situations and costly backlash.

Each instrument that comes into contact with the supply chain needs to be up to quality standards, whether that instrument is a pipette used to measure liquids, or simply a temperature gauge to measure the temperature of the lab itself. The proper calibration of these critical instruments ensures that the end product is safe for consumer use and meets regulation standards.

The calibration of instruments in such a highly regulated industry, like the pharmaceutical industry, should be performed in an accredited lab where proper calibration can be guaranteed. A lab that meets ISO/IEC 17025 and NIST standards further ensures that the instruments will be performing within the utmost accuracy.

INSTRUMENTS TO CALIBRATE

There are certain instruments in the pharmaceutical industry that are critical for calibration. These instruments have a direct correlation with the quality of the end product. From ensuring the right amount of grams are put into a product to measuring the viscosity of a liquid, the calibration of all these instruments ensures no mistakes are made along the production line.

PIPETTES

A pipette measures and transfers the accurate amount of fluid into an object or product. The slightest variation to a recipe could result in consequences to the consumer. Pipettes will need calibration for a few reasons. Depending on the liquids used in the pipette, some volatile liquids and chemicals can corrode the pipette throwing off calibration. Pipettes that are used intensively will need calibration more often than others. Further, air temperature and humidity can affect the calibration and accuracy of a pipette. Most pipettes can be calibrated every six months, but under the strict regulations of the pharmaceutical industry, quarterly calibration is recommended.

TEMPERATURE GAGE

As mentioned above, the temperature in a lab can throw off the calibration of other instruments. Further, there are some materials used in the production of a product that must stay within a certain temperature, or else risk spoilage. Even a five degree difference in accuracy could risk the integrity of a product. The calibration of a temperature gage ensures that the lab stays within optimal temperatures for the safest production of pharmaceutical products.

VISCOMETER

A viscometer measures the consistency of liquids. In the pharmaceutical industry, the viscosity of a liquid can alert manufacturers to issues that they are unable to see within the product. It can also be used to decide when a batch is ready to be packaged and sold. If a viscometer is thrown off calibration, mistakes in the production of a batch could affect the well-being of the consumer. Calibration of a viscometer can determine that the viscosity of all liquids produced in a pharmaceutical lab are consistent

PH METER

A pH Meter can be used in liquids and in some solid states. The meter is used to calculate the acidity, neutrality or alkaline measure of a product. Good practice for pH meters actually recommend that the pH meter is calibrated more than once a day in-house, and then sent out for calibration in an accredited lab every six months.

CALIBRATION IN AN ACCREDITED LAB

In a highly regulated industry there is no room for error. An accredited lab can give proof and peace of mind that all instruments were calibrated up to regulation standards. When searching for an accredited lab, it is important that the lab follows ISO and NIST standards.

STANDARDS

What does ISO mean anyway? The International Standards Organization introduced ISO 17025 specifically as a written guide for calibration facilities to follow. If a calibration lab is ISO 17025 certified, that means they have a third-party audit their practices to ensure quality performance.

What does this mean for a pharmaceutical manufacturer? If instruments were sent away to be calibrated by an instrument manufacturer, most often those instruments are only calibrated to the bare minimum. In such a highly regulated industry, instruments need to be calibrated to the standards put forth for the pharmaceutical industry. An ISO accreditation ensures that those calibrating the instrument are aware of the regulations and will calibrate it to the utmost accuracy.

CORRECT DATA

When sending the instruments back to a manufacturer for calibration, there is no guarantee that the instruments will stay in spec until the next suggested calibration date. At an accredited lab, documentation is provided with clear outlines of each calibration. It will show to what the instrument was calibrated and when it should be calibrated again. Further, this type of documentation is often required by regulating authorities. Having documentation ensures that all of the data collected until the next calibration date is correct.

BEST PRACTICES

One way to spot a top-of-the-line accredited calibration lab is by the quality practices they implement upon their own lab. One common best practice is to use 5S. 5S is a Japanese quality improvement technique which utilizes five strategies to improve product and service quality; sort, set in order, shine, standardize and sustain. A calibration lab implementing best practices such as this guarantee instruments will not get lost and will rarely be behind schedule.

CONCLUSION

Calibration in the pharmaceutical industry is a must. It keeps consumers safe and a business safe. With the recent spike in pharmaceutical recalls, it is best to calibrate instruments to ensure the product does not become contaminated. Every instrument that can be calibrated in the lab, should be calibrated and it should be calibrated correctly.
The best way to ensure instruments are calibrated correctly is by sending them to an accredited lab with an ISO/IEC 17025 certification following NIST standards. An accredited lab will be able to provide documentation that the instruments have been calibrated to industry standards. Further, an accredited lab should be following best practices and quality standards in order to calibrate instruments to the utmost accuracy.