Technical & Validation Services

What Are Sampled’s Technical Services?

Fridges, freezers, ICH stability chambers, incubators, and photostability cabinets require routine maintenance and repair as well as validation to ensure they operate within specified parameters, maintain data integrity, and continue to meet regulatory and quality-compliance requirements. Our 25+ years of expertise and rapid response time to unplanned events helps us maximise your equipment uptime and functionality while ensuring regulatory compliance with comprehensive, expert-driven technical servicing and validation solutions.

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Equipment Servicing

Routine Servicing

We offer tailored solutions for everything from servicing a single chamber to maintaining your entire stability suite, including critical spares packages. For a typical planned visit, the actions listed below will be performed (where applicable) by the engineer at the service intervals specified in your maintenance and service agreement.

Mechanical and electrical inspections and testing of equipment with regard to operational serviceability and safety	Testing of internal alarm systems and connection to remote alarm systems
Cleaning and sanitisation of all pure water containers, pipework, reservoirs, pumps and ancillary systems	Inspection and calibration of Data Logger installation
Planned replacement of consumables i.e. seals (if relevant), water system cartridges, ultrasonic generators and lamps to maintain the chamber integrity	Calibration of meters using instruments that are traceable to National Standards
Maintenance of electrical and mechanical assemblies	Issue of detailed maintenance visit documentation indicating the inspections performed and the general condition of the equipment

Our routine services include cleaning of all critical systems and determining the operational functionality of the system. We provide robust documentation of our routine maintenance services to ensure regulatory compliance, including a maintenance visit protocol. This regular maintenance programme safeguards against equipment failure, ensuring equipment uptime is maximised to support on-going storage needs.

This preventive maintenance approach helps to ensure the long-term reliability and performance of each piece of equipment. Performing maintenance activities on a regular schedule ensures your operations can continue as normal.

Breakdown Support to Maximise Uptime

We provide responsive 24-hour breakdown support. In the event of a breakdown, we dispatch our expert team of engineers to diagnose the issue and restore the equipment to full operational performance with minimal downtime. We can also provide storage space for any affected samples until the issue is resolved.

Our technical team is capable of performing maintenance and repair on a wide range of equipment linked to testing and storage. This includes but is not limited to:

• Cycling chambers
• Fridges
• Freezers
• ICH stability chambers
• Incubators
• Photostability cabinets

Expert-Led Calibration Service

We provide a calibration service that determines the accuracy of your equipment and any associated systems, utilising our state-of-the-art instrumentation, traceable to national standards. This gives you peace of mind that your equipment is working within tolerance and compliance standards.

High-Quality Part Supply

We supply all necessary parts throughout our certified supply chain. We have access to parts from various manufacturers, ensuring we are well-equipped to get your systems back up and running quickly and efficiently.

Precise Cloud Monitoring Systems

We provide environmental monitoring systems that ensure you have a comprehensive overview of conditions in your equipment and will alert you if anything deviates from specification.

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Protect Your Operations with Fast, Expert-Backed Technical Services

Expertise Ensures Optimal Machine Function

Our technical services team has broad expertise in the repair and maintenance of sample storage and testing equipment. Our knowledge and experience put us ahead of competitors, and by trusting us with your technical needs, you know you’ve got world-class experts on your side. We can help you resolve minor problems with a single phone call.

Fast Response Minimises Downtime

Delays in getting a drug to market or obtaining valuable sample data can result in significant revenue loss and lengthy re-testing. This makes fast-responding technical support crucial. Many of our clients work within a very tight tolerance deadline and only have 24 hours to get a system back to specifications before they have to report it to the regulatory authorities and carry out impact studies on the affected samples. If something goes wrong, you can contact us immediately, and we will dispatch a team of engineers to resolve the issue. We act as a single point of contact for maintenance and repairs, allowing your staff to focus on higher priority operational tasks while we resolve issues in the background.

Robust Documentation

We conduct the same level of tests in-house to support our fully MHRA licensed facilities as we offer through our outsourced technical services, giving us firsthand insight into the documentation standards required by regulators. When you work with us, you can trust that our thorough documentation will meet the expectations of auditors and regulatory bodies.

Reliable Compliance

Our technical services team uses only state-of-the-art equipment that is traceable to national standards. This means we are best placed to ensure your instrumentation functions optimally and achieves maximum uptime. By staying ahead of the curve with our technical expertise, your equipment will run more consistently with less chance of excursion. This means your projects will run smoothly, you will remain regulation-compliant, and you won’t need to spend time on internal investigations.

Leverage Expertise with a Collaborative Approach

We view our clients as collaborative partners and are fully committed to ensuring the success of their projects. With our expertise and experience, we offer a highly consultative service, sharing our wealth of knowledge to help you succeed. We are ready to provide our technical expertise immediately in the event of an auditor site visit or regulatory inspection.

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Equipment Validation

Our validation services provide a robust, documented analysis of your equipment’s performance capacity. Our team uses state-of-the-art equipment to provide you with a wealth of data for demonstrating operational performance and ensuring regulatory compliance.

We test multiple locations within a piece of equipment over a typical 24-hour period to demonstrate compliance with both internal and regulatory standards. This provides a wealth of evidence for you to present to regulators and auditors. Our highly trained technical services engineers also perform validation testing on new and existing equipment to ensure compliance and optimal performance, helping you get it right the first time.

Comprehensive Validation Process for Long-Term Compliance and Performance

Equipment Mapping and Validation of Controlled Spaces

New equipment and controlled spaces require validation to ensure they match the description and perform as described and intended. Our equipment and space mapping service ensures that your infrastructure complies with regulatory guidelines. We also provide validation services for older equipment to ensure it adheres to the same regulations.

Installation Qualification – IQ

Our validation team inspects your new equipment to ensure it physically matches the description given by the supplier. This includes, but is not limited to, checking the chamber’s mechanical and electrical installation, features, and installed options.

Correct installations are essential for efficient processes and to avoid breaches during regular audits. Our services ensure your instruments are installed and configured in line with regulations.

Operational Qualification – OQ

Our team confirms that your new equipment matches the operational description provided by the supplier. This includes, but is not limited to, the achievable range of temperature, humidity, and light exposure, as well as the operational functionality of the installed components.

Performance Qualification – PQ

We test the performance and accuracy of your new equipment using multiple temperature and humidity probes. We test the extremes to ensure that the new equipment is regulation-compliant.

We offer a yearly renewal of this validation programme, allowing you to demonstrate to regulators that you consistently meet their requirements.

Our technical team is ready to perform validation services on a range of equipment linked to sample storage and testing. This includes but is not limited to:

• Fridges
• Freezers
• ULT freezers
• ICH stability rooms/chambers
• Incubators
• Photostability cabinets
• Cycling chambers
• Warehouses

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Ensure Equipment Compliance and Performance With Robust Validation Services

Achieve Global-Standard Validation with Long-standing Expertise

Our validation services team has extensive expertise in operating drug and sample testing equipment. We are a global company offering outsourced ICH stability testing, so we know everything about how these machines work and how to validate them within regulatory standards. All data is backed up automatically, not only locally on the probe, but also on the computer it is linked to and geo-redundantly in the cloud.

Simplify Regulatory Processes With Robust Documentation

We conduct the same level of tests in-house to support our fully MHRA licensed facilities as we offer through our outsourced validation services, giving us firsthand insight into the documentation standards required by regulators. When you work with us, you can trust that our thorough documentation will meet the expectations of auditors and regulatory bodies.

Reduce Risk with Reliable Services

Our validation services team uses only state-of-the-art equipment that is traceable to national standards. By staying ahead of the curve with our validation services, your equipment will run more consistently with less chance of excursion from established operating conditions. We use wireless equipment which means no trailing wires inside or outside the chamber. This provides a 99% reduction on possible trip hazards in comparison to other technologies used. Wireless processes also prevent loss of chamber integrity.

Leverage Expertise With a Collaborative Approach

We view our clients as collaborative partners and are fully committed to ensuring the success of their projects. With our expertise and experience, we offer a highly consultative validation service, sharing our wealth of knowledge to help you succeed.