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. 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. Proper calibration in the pharmaceutical industry ensures that the end product is safe for consumer use and meets regulation standards.
The following instruments are ones that should be calibrated in the pharmaceutical industry on a regular schedule:
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 calibration in 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 in the pharmaceutical industry of a temperature gage ensures that the lab stays within optimal temperatures for the safest production of pharmaceutical products.
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 in the pharmaceutical industry 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 the pharmaceutical industry is the best way to ensure that any product that comes in contact with a consumer is safe to use. The smallest calibration error could result in devastating results, not only for the consumer, but for your business. Using an accredited calibration lab will also ensure that all the instruments are calibrated up to FDA standards.