Efficient identity verification of incoming raw materials
Quick and easy verification of raw materials saves time and money for pharmaceutical producers. By verifying materials without opening the plastic bags and other containers, the raw materials do not need to be brought into cleanrooms which means that the verification can be done without disrupting the ongoing production.
“Identifying raw materials with handheld Raman devices increases productivity and reduces the risk of manual errors.”
– Erik De Kort, Director Pharmaceutical Affairs, Focus Care Pharmaceuticals B.V.
The Serstech Solution
Serstech Arx+, Serstech 100 Indicator and ChemDash Pharma are designed to be easy and quick to use. The low weight and the small form factor make Serstech’s instruments truly handheld and their eight-hour battery life allows them to be used a full workday without recharging.
The solution is Title 21 CFR part 11 compliant and detailed IQ/OQ documentation is available through your Serstech partner. With a complete audit trail and data integrity you can trust, Serstech’s solution is your perfect companion for inventory management and goods inspection.
Technology That Supports You
Serstech’s instruments and software support your processes and can be customized in several ways. One is the workflow, that can be defined by your system administrator to fit your needs and current process. Another is the reports, for which templates can be defined by the admin and then can be filled our and signed by the user. Yet another is the flexible user rights management, which allows the administrator to set exactly what each user is allowed to do and edit in the system.
Serstech’s solution supports your needs and process and allows you work in the way that is the most efficient for you. Technology that supports you.
Efficient verification of incoming raw materials without opening the original package. Given the workload and lead time, efficiency gain can be achieved by replacing commonly used, time consuming and labour intensive analytical techniques.
Create Your Own Libraries
Serstech provides substance libraries that have been created and validated with the Serstech 100 Indicator, including pharmaceuticals, narcotics and many other types of chemicals. You can easily and quickly create your own libraries and share them with other instruments through Serstech’s ChemDash Pharma software. Spectra can be viewed, named and exported and you can easily create, print and share reports.
Serstech provides factory libraries, including raw materials, such as excipients and coating agents, and these can easily be combined with user-made substance libraries. Measurements from one instrument can easily be shared with one or many other instruments.
ChemDash Pharma Software
ChemDash Pharma allows you to manage your measurements and your custom-made libraries. It maintains a complete audit trail and allows you to set detailed user rights for users of each instrument. With ChemDash Pharma, you can connect several instruments to the same computer and share information between the instruments. Any libraries you create can easily and quickly be shared between instruments and any additional information you have added to each substance will be available to the users of the instruments.
Low Weight and Easy to Use
The Serstech 100 Indicator only weighs 650 grams, which makes it truly handheld and the small form-factor makes it easy to use with one hand. The battery is designed to last all day and its intuitive user interface allows for repetitive tasks with a single press of a button, e.g. verification of the content of many containers. Serstech 100 Indicator was initially designed to meet the tough standards of military and security staff and is robust, reliable and it works in any environment. It is water, shock and vibration proof and can handle any temperature between -20 and 50° C.
In a Nutshell
- Customizable workflows to fit your process and needs
- Rechargeable battery lasting more than eight hours
- Create your own libraries and add new substances
- Complete staff training done in hours
- Multicomponent identification
- Multi-level user access
- Title 21 CFR Part 11 compliant
- Quick and easy to clean
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