RvA accredited
All calibrations done on-site

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.

Kalibra helps

Do you have any questions or are you looking for advice?

Please contact Martijn Rienks

tel: +31884846977
email: Martijn.Rienks@kalibra.nl

Martijn Rienks Kalibra

You can also ask your question via our contact form or request a quote via the button below.

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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

Total approach

Kalibra offers a wide range of services and is eager to unburden its customers. Most calibrations and validations can be performed in-house. Should there be any activities that we cannot carry out ourselves, we will gladly outsource these for you. This gives you a single point of contact for all your calibrations and validations.

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

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.