Traceability, management and data integrity
The new concept of automatic gloved hand sanitization
Inspections by the regulatory authorities in the pharmaceutical industry have become increasingly stringent in recent years. Regulators are focusing on a fundamental theme: data integrity. They want to be assured that all relevant events are recorded and are legible and traceable. The FDA has repeatedly found cases of irregularities within companies that had either not applied robust systems to reduce patient risks, not improved situations where data reliability could be compromised nor investigated the causes of data errors. The current requirements are represented by the acronym ALCOA, which says data must be:
Attributable — who did what and when was it done?
Legible — data must be permanently recorded and readable.
Contemporaneous — data should be recorded at the time the job is done and there should be references to date and time.
Original — the information is the original registration or a certified copy.
Accurate — there must be no mistakes or modifications without registered corrections.
In addition, the data must be complete (including all replicate or sample reanalysis data), consistent (coherent application of time reference in the waiting sequence), durable (recorded on worksheets, lab notebook or electronic media) and available (accessible to audit/ auditing throughout the life of the record).
The integrity of data generated by regulated pharmaceutical companies and laboratories matters most, because properly recorded information is the basis for manufacturers to assure product identity, strength, purity, and safety. The non-compliances found in the integrity of data, leads to warning letters and regulatory action from the agencies.
Consider the very definition of data integrity: Data integrity is the accuracy and consistency of stored data, indicated by an absence of any alteration in data between two updates of a data record. Data integrity is imposed within a system at its design stage through the use of standard rules and procedures and is maintained through the use of error checking and validation routines.1
Some of the activities to prevent microbiological contamination implemented inside a pharmaceutical clean room are not easily performed in line with the data integrity indications.
Routine disinfection of gloved hands, even if considered extremely important practice, is one such example. Currently, the market offers automated systems that require manual operations to both record individual disinfection events and operate the instrument itself.
In the R&D landscape, a leading Italian company in the contamination control market, AM Instruments, has invested heavily in a GMP program. The new concept — My&Clean+ — is for the automatic disinfection of gloved hands. It solves the two common problems: an automatic system that can trace all the disinfection operations and at the same time eliminate the risk of cross-contamination.
Before looking at its features in detail, there are two interesting points from the main guidelines for glove disinfection to identify.
According to Volume 4 EU Guidelines to GMP Annex 1, “… For every worker in a grade A/B area, clean sterile (sterilised or adequately sanitised) protective garments should be provided at each work session. Gloves should be regularly disinfected during operations. Masks and gloves should be changed at least for every working session.”2 According to FDA Pharmaceutical cGMP: “After initial gowning, sterile gloves should be regularly sanitised or changed, as appropriate, to minimise the risk of contamination. Personnel should not directly contact sterile products, containers, closures or critical surfaces with any part of their gown or gloves.”3
Where gloves are required these should be put on using a method designed to prevent the ungloved hand from touching the clean or sterile outer part of the glove. Once in the cleanroom, gloved hands should be subject to periodic hand sanitization.4
AM Instruments have created an automatic system for the disinfection of gloved hands. The My&Clean+ responds to the need and very definition of data integrity, both in terms of accuracy and consistency of the data and in terms of design. The entire system has been developed in order to trace, record and manage one of the most delicate operations in a controlled contamination environment.
The MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 document provided some prescriptions to design systems in a way that encourages compliance with the principles of data integrity. Examples include:
- Access to clocks for recording timed events
- Accessibility of batch records at locations where activities take place so that ad hoc data recording and later transcription to official records is not necessary
- Control over blank paper templates for data recording
- User access rights which prevent (or audit trail) data amendments
- Automated data capture or printers attached to equipment such as balances
- Proximity of printers to relevant activities
- Access to sampling points (e.g. for water systems)
- Access to raw data for staff performing data checking activities.
My&Clean+ meets each of these requirement thanks to versatile user interface software, that is capable of connection with existing facility SCADA system or working alone.
Clean, record, share – Without touching the large screen operators can see at a glance how much time remains before their next sanitization is due. The device recognises the individual operator and via a simple gesture from the operator, the gloves are safely disinfected. Due to the positioning of hand sensors there is no need for direct contact with the machine. The My&Clean+ then validates and records the gloved hand sanitisation. It is also possible to check directly from the display the level of liquid available in the trigger spray bottle. The My&Clean+ system can operate with any commercially available IPA spray bottle on the market today. There is no need to change from your existing supplier of IPA. Visual and acoustic alarms signal a successful or unsuccessful cycle, the absence of a bottle, depletion of liquid or open door.
According to a company’s own standard operating procedure (SOP), the number of sprays can also be customised. Multiple sanitisation devices can be managed from a remote location via a computer connected to the network with a web interface. It is also possible to register new operators, check the level of liquid, examine and generate reports from the remote computer. Beyond the manual disinfection operations with sprays and current automatic dispensing devices, which are all very similar to each other, there are no tools that ensure total traceability of the use of the original disinfectant bottle. My&Clean+ simplifies procedures. Operators are continuously traced for any operation they perform (registration, disinfection, error and repetition of operation etc.). This removes the need for manual recording of operations using pen and paper which could be edited and therefore easily contestable at the inspection stage.
- PDA Data Integrity Seminar – Ireland May 2015
- Volume 4 EU Guidelines to GMP Annex 1: 44.
- FDA Pharmaceutical CGMPs 21cfr211.28(b): A. Personnel
- S., (2009). Hand Washing-A Critical Aspect of Personal Hygiene in Pharma, Journal of Validation Technology, 15 (4): 50-55