19
Nov

FDA: more frequent observations concerning the sanitisation of gloved hands and their monitoring

The increasingly frequent observations regarding the lack of sanitisation of gloved hands in controlled environments and above all the impossibility of real monitoring of sanitisation operations find the ideal solution in My&Cean+, the only device capable of tracking all operations while cancelling the risk of cross-contamination.

This is not only a problem related to failure to comply with procedures and behaviour in a classified environment. What is really being highlighted more and more often is the lack of certainty that gloved hand sanitisation operations are carried out in the correct manner, at the right intervals and that, in the event of failure, they can be repeated.

Inspection bodies observe improper behaviour in the management of hand sanitisation cycles, operations that are in fact not regulated but are fundamental for the contamination control in pharmaceutical production environments.

Based on our thirty years of experience in the pharmaceutical industry, we have underlined on many occasions what we believe to be the keystone of the issue: having total traceability of operations in compliance with Data Integrity.

Allow us to consider one of the FDA’s many observations:

Poor Aseptic Behavior 

Critical aseptic processing operations are not appropriately controlled. Our investigator observed that operators who performed ISO 5 manipulations exhibited poor aseptic practices during production of (b) (4) Lot (b)(4). For example, operators: 

  • failed to sanitize gloved hands after touching surfaces such as curtains and computer touchscreens.
  • conducted manipulations using rapid movements, rather than slow and deliberate aseptic technique.

…You did not extend this training to supervisory staff. You also did not address how you would verify the effectiveness of the training

FDA Warning Letter (09 June 2020)

My&Clean+ is the ultimate solution

My&Clean+ is a system that can record all gloved hand sanitisation operations, their correct execution and frequency, indicating the possible need to repeat the operation in case of failure.

AM Instruments has created an ultimate system that simultaneously solves the problems of data consistency and reliability and cross-contamination.

But let’s focus on how My&Clean+ works and how it comprehensively responds to the pressing requirements of FDA as well as of all inspection bodies.

My&Clean+ Hand Disinfection
My&Clean+ Station Hand Disinfection

Total traceability

The operators, equipped with RFID bracelet, are recognised by the machine which indicates the exact moment when they will have to perform the hand sanitisation. In case of failure the operation can be repeated. In this way My&Clean+ ensures full adherence to Data Integrity.

All information is in fact attributable (via RFID), readable (reporting), simultaneous (all data relating to the operator are recorded at the exact moment in which the operations take place), original (in particular not modifiable) and accurate (full correspondence between operation and data).

Simple and safe operations monitoring

My&Clean+ ensures full data management especially in GMP terms, as it fully adheres to what regulatory authorities consider fundamental in data collection and integrity:

  • Access to clocks for recording timed events
  • Accessibility to batch records in the areas where the activities take place so that there is no need for data recording and subsequent transcription into official records
  • User access privileges that prevent (or track) the modification of data
  • Automatic data acquisition or printers connected to equipment
  • Access to raw data for staff performing data control activities
My&Clean+ Gloved Hand Sanitisation

Total elimination of cross-contamination risks

The disinfectant is dispensed directly from its original bottle placed inside the device, an absolute novelty that eliminates any risk of transfer of contaminants from one surface to another by preventing the bottle from passing through the operator’s hands.