The calibration of the systems and sensors currently in use, along with the complete elimination of identified deviations, constitute fundamental components of a qualification. These are essential for the subsequent validation of a critical process within a GxP context.
For quite some time, the question of whether to use a wired data recorder or a wireless battery-powered data logger for the validation of thermal processes in the GxP environment has been discussed.
In today's blog post, we would like to take you on a journey through time to the origins of Kaye and the company's early steps in the field of validating thermal processes in the pharmaceutical and biotechnological industry.
EN-285 is a European standard that sets guidelines for the sterilization of medical devices in healthcare facilities. When a person is expected to use EN-285 in a regulatory sense, they are required to adhere to the specific procedures and requirements outlined in the standard to ensure the effective sterilization of medical equipment.
When managing the reliability and performance of your equipment, having a solid warranty and service plan in place is key. A Kaye Service Agreement, also known as an EMA (Equipment Maintenance Agreement), is an invaluable resource that offers a multitude of benefits.
While it might not get as much publicity as validation equipment, your calibration equipment is a critical part of any viable thermal validation system. Having the proper equipment, equipment that you can trust, is essential. There is no place for inconsistent measurements in pharmaceutical and biotech industries, accuracy is key. It is essential to ensure that your validation system provides accurate information, and this is where calibration plays a crucial role in guaranteeing precise measurements. At Kaye, we offer a large variety of calibration equipment, and our goal is to offer everyone a solution that can fit their needs. In this blog post, we are going to look at some of the basic information to consider when selecting calibration equipment.
Precision is paramount in the realm of Kaye products, making the choice between Resistance Temperature Detectors (RTDs) and Thermocouples (TCs) is essential for accurate measurements. Let's dive into their long-term stability comparison.
Active Directory* (AD) is a directory service developed by Microsoft specifically for Windows domain networks. Its primary function is to proficiently manage users, computers, and various resources within a networked environment. Within Active Directory, information regarding all network objects, such as, users, groups, computers, printers, and devices, are stored and organized in a structure known as the directory tree. This architecture enables easy discovery and management of objects across the network.
When assessing the effectiveness of a sterilization process, calculating the lethality using the F0 method is crucial. One significant consideration in this calculation is the duration required to eliminate a specific number of microorganisms, which can be expressed in either minutes or seconds. Using expressing time in minutes is more widely accepted and practical, understanding the differences and implications of using seconds is also important in certain scenarios. In this blog post, we'll explore the significance of expressing time in minutes or seconds when calculating lethality using the F0 method.
In industries such as healthcare, pharmaceuticals, and food processing, the use of sterile products is essential for preventing the spread of harmful microorganisms. Thermal validation is a process used to ensure that sterilization processes are capable of achieving the desired level of sterilization. This process involves exposing a product or material to a sterilization process and then testing for the presence of viable microorganisms.
Recently we presented you with information pertaining to data security and what Kaye is doing to keep your data safe. Continuing with this same topic area, there is another principle dealing with data when it comes to our Cloud-based systems. In this post, we are discussing GxP Compliance.
Unlike your car, validation and calibration equipment don’t necessarily need an oil change or their tires rotated, but there are important preventative steps you can take to help extend the life of your instruments and minimize risks for your Validation studies.