Pharmacy

Strict requirements apply to the production and development of medicines. For example, think of quality assurance such as Good Manufacturing Practices (GMP) and organisations such as the Food and Drug Administration (FDA) when exporting to the United States.

Quality assurance of research results and/or products is important. It allows you to demonstrate that products are suitable and safe for users and prevents recalls, the latter resulting in significant costs and reputation damage. Part of this quality assurance is the periodic calibration and validation of instruments in process installations, production areas, and equipment.

Request quotation
laboratoria zorg

Kalibra As An Experienced Partner In Pharmacy

With its unique total approach, Kalibra has extensive experience in pharmacy. Many of our customers have been using our services for years. These long-term relationships ensure that the work is performed efficiently and that the services provided are in line with the applicable laws and regulations and specific wishes and requirements of the customer. In addition, our unambiguous approach ensures that audits can be performed smoothly. The services that Kalibra provides in pharmacy include:

  • Calibration
  • Validation
  • Secondment
  • Consultancy

Calibration in Pharmacy 

Process Instrumentation

Kalibra provides calibration of process instrumentation in pharmacy. These activities are usually performed on location at the customer during production stops. Kalibra will always adhere to (customer) specific regulations such as access requirements, clothing rules, etc. When performing calibrations in the production process of pharmaceutical customers, the following instruments are included:

  • Pressure sensors/transmitters
  • Temperature sensors/transmitters
  • Level measurements
  • Humidity meters
  • Weighing instruments
  • Fluid meters / flow transmitters
  • pH measurements

Measuring Instruments

In addition to calibrating instruments in production facilities, Kalibra also calibrates measuring instruments in laboratories and research areas. For example, this concerns the calibration of monitoring systems, measuring instruments, and equipment:

  • Temperature sensors
  • Pressure transducers
  • Relative humidity
  • Weighing instruments (including balances)
  • Centrifuges

Validation in Pharmacy

Thermal Validation

Kalibra specialises in conducting thermal inspections. The aim is to get a complete picture of the thermal functionality of the equipment and spaces in which quality-critical products are stored or researched. Common pharmacy equipment includes:

  • Refrigerators
  • Freezers
  • Incubators
  • Ovens
  • Warehouses

Would you like to know more about validation and why the validation of devices, rooms, and processes is important? Read more about validation here.

Clean Room Validation / Contamination Control

Sterile and aseptic working is essential in pharmacy. To prevent pollution, the sector uses clean rooms and the like (LINK TO CLEAN ROOM VALIDATION PAGE). Kalibra validates room and equipment that are used for contamination control.  This includes:

  • Clean rooms
  • LAF cabinets
  • (Micro)biological safety workbenches
  • Cytostatics workbenches

Clients we are proud of

abbott logo
astellas logo

Guidelines

National and international guidelines apply for performing calibrations and validations. Reports and certificates issued by Kalibra are internationally recognised. The guidelines that are relevant to you will be coordinated with you for implementation and included in our protocols.

Accreditation

Kalibra is accredited by the Dutch Accreditation Council (RvA) to perform calibrations. We are therefore authorized to issue calibration and validation certificates bearing the accreditation logo.

Services

Kalibra specialises in calibrations and validations. In addition, we also perform (metrological) inspections. Our services at a glance:

Calibration

Calibration is the comparison of a measured value using a measuring system with an actually measured value with a standard to determine the deviation.

Validation

Validation of critical facilities, spaces, instruments, and equipment provides insight into whether requirements are met, and therefore whether an object is suitable for the intended goal.

Inspection

Metrological inspection involves testing whether a measuring instrument complies with metrological legislation. Kalibra is a formal inspection body. We carry out inspections as an independent institution. A metrological inspection guarantees objectivity and expertise.

Calibration of Measuring Instruments

Kalibra is an expert in the field of different types of calibrations. We can calibrate both individual measuring equipment as well as permanently installed measuring equipment in the production process.

Outplacement

Trained and experienced Kalibra employees are available on call for a either a short or longer period. Even a couple of days a year is possible.

Consultancy

When it comes to calibrations and validations, our consultancy services can always provide you with advice and guidance. After all, before any inspections are performed, it is important that the starting points and test criteria are well defined.

Gas detection

Kalibra is an authorized sales and service point of mercury vapor meters from Arizona Instruments (AZI). You can also contact us for the rental and purchase of mercury vapor meters.

Maintenance and Management

It should go without saying that your systems should work exactly as intended. Your employees must be able to safely operate their equipment.