My&Clean+, a new concept of gloved hands disinfection
Data integrity today is a fundamental requirement for the quality, efficiency and cost control of a production cycle, ensuring the highest level of safety. The regulatory body requires data integrity in full compliance with the GMP rules, and the company must guarantee it through continuous improvement of the processes. Furthermore, some processes are receiving even more attention due to their importance within a careful analysis of risks in production cycles. Among all, the disinfection of gloved hands. Currently, the market offers automated systems that require manual operations, both in the operational phase, with constant risk of cross contamination, and during the recording of disinfection events. The manual registration of the operations is not only easily modifiable but also contestable during the inspection phase.
Among the main deviations found, AIFA reports that “during the filling phases, the operators do not periodically perform the disinfection of the gloves”.
In the new Annex 1 it is stated that dress changing and hand washing actions must follow written SOP to reduce the risk of contamination. “Changing and hand washing should follow a written procedure designed to minimize contamination of clean area clothing or carry-through of contaminants to the clean areas….Gloves should be regularly disinfected during operations.”
According to volume 4 of EU guidelines for GMP, “… For each worker in a grade A / B area, protective clothing should be provided sterile (sterilized or properly disinfected) during each session The gloves should be disinfected regularly during operations Masks and gloves should be changed at least for each working session. “
According to FDA Pharmaceutical CGMP: “… The sterile gloves must be regularly disinfected or modified, as appropriate, to minimize the risk of contamination.The personnel should not come into contact directly with sterile products, containers, closures or critical surfaces with a part of the gown or gloves. “
AM Instruments, the first Italian company completely GMP Oriented, offers a new concept of automatic disinfection of gloved hands able to respond effectively to stringent regulatory requirements.
My & Clean+ is an automatic system able to track all disinfection operations, eliminating at the same time the risk of cross contamination.
Fully oriented to data integrity, the system records all activities on tables containing “raw” data that the management program redefines in strings containing all the information related to a specific user. The generated metadata can not be modified in any way, can be consulted and filtered to generate specific reports. In this sense we can consider My&Clean + a device that fully complies with the five golden rules of data integrity. In fact, the data generated, as per ALCOA, are attributable, legible, contemporary, original and accurate.
|LOG IN||identification of operator, generation of data||readable through table with user ID||immediate||unalterable||total correspondance between action and data|
|OPERATOR REQUEST||the user performs the operation, the operation is attributed solely to him||data can be used in a table with IDs and actions connected to it||immediate||unalterable||total correspondance between action and data|
|OPERATION||the operation involves the generation of further data (sanitizing level, lot number, number of deliveries, intervals between disinfection operations, etc.)||usable through tables: sanitization/ sanitization recipe/DB||immediate and reorganized into metadata strings||unalterable||total correspondance between action and data|
|LOG OUT||the user logs out||readable through table with user ID||immediate||unalterable||total correspondance between action and data|
My & Clean + is a system that tracks the disinfection of gloved hands, its correct execution and frequency, also notifying the need to repeat the operation in case an error occurs. The disinfectant is dispensed directly from the original bottle inserted inside the device, an absolute novelty that, avoiding the passage of the bottle in the hands of the operator, cancels any risk of transfer of contaminants from one surface to another. The sterility in use of the disinfectant is guaranteed by the bottle itself, the original packaging of which is not altered in any way during positioning and use inside the device.
My&Clean+ can be installed individually or in multiple connected devices.
From a remote location, through My&Clean+Station console, you can manage multiple devices, register new operators, check the liquid level, examine and generate reports. The device recognizes the single operator who, with a simple and immediate gesture, obtains a safe disinfection: direct contact with the machine is not necessary, thanks to a position sensor for the hands. My&Clean+ then validates and records the disinfection operation of the gloved hand. It is also possible to check the level of liquid available in the bottle directly on the display. Visual and acoustic alarms indicate the success or failure of the cycle, the absence of the bottle, the depletion of the liquid, the open door. The number of spray can be customized according to the company SOPs.
In the current market there is no device able to simultaneously guarantee the total traceability of the operation, data integrity and the use of the original bottle.
My&Clean+ simplifies the procedures and above all ensures full adherence to the requests to check the regularity of the disinfection of the gloved hands and the maintenance of sterility during the relative operations.