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.

For more information on the My&Clean+ product range please contact:

UK & Ireland
AB Scientific | info@abscientific.com | www.abscientific.com

Italy & rest of world

AM Instruments | export@aminstruments.com | www.aminstruments.com

REFERENCES

1. PDA Data Integrity Seminar - Ireland May 2015

2. Volume 4 EU Guidelines to GMP Annex 1: 44.
3. FDA Pharmaceutical CGMPs 21cfr211.28(b): A. Personnel
4. Sutton. S., (2009). Hand Washing-A Critical Aspect of Personal Hygiene in Pharma, Journal of Validation Technology, 15 (4):
50-55