ISO/IEC 17025:2017 is the international standard that defines the competence, impartiality, and consistent operation of testing and calibration laboratories. In today’s business and regulatory landscape, accurate, traceable calibration services to meet compliance requirements. Achieving ISO 17025 calibration ensures that laboratories demonstrate both technical proficiency and global credibility. For organizations evaluating calibration labs, this standard is essential in ensuring reliability, regulatory alignment, and long-term trust. The adoption of ISO 17025 is not simply a compliance exercise but a strategic investment in quality and operational excellence.
In precision-driven industries such as pharmaceuticals, biotechnology, and life sciences, calibration, verification, and validation form the foundation of effective quality assurance. While often misunderstood or used interchangeably, each process serves a distinct role in ensuring measurement accuracy, operational reliability, and regulatory compliance. Understanding how they differ—and work together—is essential for maintaining consistency, safety, and efficiency across operations.
Maintaining compliance in the pharmaceutical and biotech sectors is becoming increasingly complex. Regulatory bodies such as the FDA and EMA impose strict requirements to ensure product safety, data integrity, and patient protection. Non-compliance can lead to severe consequences, including recalls and reputational damage.
In today's highly regulated pharmaceutical and biotech environments, temperature mapping is a non-negotiable process to ensure sterility, compliance, and product integrity. At the heart of this operation lies the Kaye Validator AVS, a 21 CFR Part 11 compliant validator engineered specifically for precision-driven validation tasks. As regulatory scrutiny intensifies and digital transformation accelerates, the ability to streamline qualification processes using innovative, wired validation systems like the AVS is becoming mission-critical for QA teams worldwide.
Accurately measuring surface temperature is critical in many controlled environments, particularly in sensitive pharmaceutical and biotechnological processes. However, this seemingly straightforward task becomes increasingly complex in vacuum conditions, such as those found in freeze dryers. Traditional temperature validation methods often fall short, being time-consuming and vulnerable to setup errors. Enter the Kaye Sensor Surface Adapter—a professional and secure solution developed to meet the highest standards of validation and monitoring.
Sustainability is not an option; it is a necessity. As a leading global company in validation systems for the pharmaceutical and biotechnological industries, Kaye, a subsidiary of Amphenol, is committed to shaping a sustainable future. We recognize the crucial role that sustainable practices play in protecting our planet and commit to integrating sustainability into every aspect of our operations.
When it comes to high-precision thermal validation in closed chambers—such as depyrogenation tunnels, drying ovens, or high-temperature test environments—real-time data loggers are indispensable tools. They offer unmatched flexibility in handling and placement while enabling continuous monitoring and validation. However, like all technologies, they face limitations—especially when operating in extreme heat.
In a time when companies face increasing pressure in a rapidly changing market, integrity is an essential pillar for sustainable success. At Kaye, a company of Amphenol, integrity is not just part of our corporate philosophy but also the standard by which all our decisions and actions are measured.
In the dynamic world of technological and automated solutions, innovation is the key to success. At Kaye, a subsidiary of Amphenol, we have embraced this core value for over 65 years. Our continually innovative approaches, which push the boundaries of what is technically possible to develop practical solutions, have established us as a leading provider in the validation of thermal processes. The needs of our users are at the forefront—from developing technologically outstanding products to meeting all regulatory requirements in the pharmaceutical and biotechnology sectors.
At Kaye, a subsidiary of Amphenol, we recognize diversity as a crucial component of our corporate culture. It fosters creative solutions and drives us to incorporate a global perspective into our daily decisions, which ultimately enhances our success and innovation.
The aerospace industry sets particularly strict and accurate standards for thermal processing, outlined in specifications such as AMS 2750 (current version: AMS 2750F) and the industry manual by NADCAP (National Aerospace and Defense Contractors Accreditation Program). Accurate measurement and calibration of the temperature sensors used, as well as all process monitoring and temperature-dependent system components, play a central role. The aim of this blog post is to give a brief description of the ice point references used and to highlight their importance in complying with guidelines.
In the ever-evolving modern business world, one constant remains: the indispensable value of ethics. At Kaye, a subsidiary of Amphenol, we have declared ethics as one of our core values, and today we would like to provide you with insight into what this means for us concretely and why it is of utmost importance in our work.