The SL150 temperature logger is designed to travel directly with goods and provides a detailed date and time temperature profile which can be used to highlight any problems
With heightened awareness of issues relating to the safety and quality of a wide range of perishable products and goods, increased legislation is leading to the implementation of new procedures and controls for storage and transportation.
However, the effectiveness of any controls can only be as good as the equipment, procedures and, above all, diligence of the personnel involved at each and every stage.
Unfortunately, as equipment and systems become more sophisticated, the opportunity for error or fraudulent misuse increases and therefore unambiguous and strict product traceability systems are vital to ensure complete product audit trails.
Temperature control is one of the most critical factors in ensuring the quality of perishable goods such as food drugs, medical products and pharmaceuticals, especially during transportation.
Routings can be complex with goods often being transhipped using several different methods and carriers.
Data loggers from Signatrol are already playing a vital role in this area by helping to monitor and record temperatures in applications as diverse as the shipping of star fruit from Malaysia to the transportation of blood products around the globe for the British Armed Forces.
Direct monitoring of the temperature of the product is infinitely more reliable (and hence more diligent) than the general monitoring of the environment inside vehicles and containers.
The important factor is that compact portable loggers can monitor the total journey even when this involves several stages of responsibility.
The SL150 temperature logger is specifically designed to travel directly with goods and provides a detailed date and time temperature profile which can be used to highlight any problems so that corrective action can be taken.
The data logger is housed in a fully weld sealed crevice free, robust food grade plastic tag, which is only 10mm thick.
The SL150 uses a patented induction technique for set up and data down load which means that there are no plugs, sockets or entries of any kind.
Powered by an internal battery, the unit can be selected to log at intervals from 1 minute up to 255 minutes and has a measurement range from -30°C to +70°C.
The standard SL150 has a number of special features which facilitate its use in transport applications including a convenient through hole which allows the unit to be security-sealed to the consignment.
Now, in order to meet requirements from Signatrol's US customers, the special version SL150-HS unit has been developed with special high security software which ensures it has full compliance with the USA's Food and Drugs Agency FDA 21 CFR Part 11 legislation ensuring the validity of stored electronic data.
This federal regulation also sets out the criteria under which the agency considers electronic signatures and hand written signatures executed to electronic records, to be trustworthy, reliable and generally equivalent to paper records and hand written signatures executed on paper.
Although this regulation has no official status in Europe any companies that export critical products to the US need to comply.
Brian Turner, MD of Signatrol, believes that similar regulatory control is not far away and the SL150-HS provides all the necessary controls over systems and procedures to fully satisfy those requirements not just of FDA, but also HACCP and EFSIS including the provisions for Electronic Signatures.
There are several key elements of the FDA standard as follows; * The ability to discern invalid or altered records.
* The ability to generate accurate and complete copies of records. * Protection of records to enable their accurate and ready retrieval throughout the records retention period.
* Limiting system access to authorized individuals.
* Use of secure, computer generated, time stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.
* Use of authority checks to ensure that only authorized individuals can use the system.
* Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: * The printed name of the user.
* The date and time when the signature was executed; and * The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
* Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.
Signatures should; * Employ at least two distinct components such as an identification code and password.
* Be used only by their genuine owners; and * Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two more individuals.
All the data in the SL150-HS logger is stored in an encrypted form to ensure that the data cannot be altered or in any way manipulated and yet they can be archived or exported to other sites (including FDA) for analysis.
System access is tightly controlled by a Systems Administrator who registers via Signatrol's website or by telephone and is responsible for entering a number of authorised 'Users' onto the system who are identified by a unique user code and pass word.
For added security, the system also prompts the user to change his pass word at six monthly intervals.
A contiguous audit trail of SL150 tag activity and stored data is maintained on the primary PC, from which all tags are issued.
Separate viewer software, available free from the website, enables any number of users to examine the data or provide secondary (un-signed) copies.
The construction of the system is such that, even though the transportation and distribution may be outside the direct control of the company, it can still be maintained as a 'closed system' within the FDA definition.
Alternatively, it can be run as an 'open system' by configuring the system to run with manual, rather than electronic, signatures.
Internal monitors, contained within the tag, provide the user with automatic notification that re-calibration (12 monthly intervals), is required or that the batteries are over their recommended four years life, when the loggers can be returned and traded in for replacement units.
In addition, the SL150 can be individually protected by a nine character ID code which is stored within the tag for life and is required to issue a tag or to change any of the option settings.
There is little doubt that electronic records offer significant advantages, not only eliminating mountains of paper work, but also speeding up data processing and information exchange.
However, in any systems or process, Critical Control Points must be clearly identified and monitored so that effective corrective and pre-emptive action can be taken.
This is onerous enough within the confines of any organisation but becomes ten times more complex once products or goods are transported externally.
As Brian Turner concludes: "Setting up any electronics record system is only the start and companies must ensure a consistent process to maintain an effective level of security and control.
Although products like our SL150 may appear to have only a tiny part to play in any process, they provide a vital continuity link in a vitally important area." Signatrol is the dedicated data logging division of Status Instruments and the SL 150 is just part of the company's extensive range of standard and bespoke data loggers and recorders.
