Posted: Wednesday, 30 June 2021 @ 11:44
The rapid implementation of mass vaccinations during
the last six months is extremely welcome news.
However, there is still much to do to
distribute vaccines into communities worldwide
with considerable logistics and distribution challenges.
It is sure that the announcement of a
vaccine will have got counterfeiters ears twitching and hands rubbing
at the thought of the many millions to be made from
(at best) water in a vial. The security
and voracity of the vaccine supply chain will be critical to the supply process
and public reassurance.
Unisto has a long history of supplying pharmaceutical manufacturers
and distributors with security products that are written into their manufacturing processes. Many of the multi- national drug companies that have been working on a Covid-19
vaccine use Unisto
security seals for their applications. Normally, seals are there to prevent accidental contamination providing a stop
and think step before opening
a keg or IBC and introducing the contents
to the formulation and an audit trail of seal numbers for traceability.
We were called one day by a large
pharmaceutical manufacturer that had
accidentally dropped an opened plastic seal into a drug mix. The caller
asked us for a detailed
material specification of the seal in question
and we were told that if we were unable to provide
it then about £250,000 worth of part finished ingredients would have to be destroyed. After some anxious
hours, our specifications came through and all was well, the processes could be
completed; sighs of relief
Security seals recommended for pharmaceutical and chemical use, at ambient
or controlled room temperature, are most usually
polypropylene or polyethylene. For low temperature use, 5°C and below, a metal seal is recommended, such as a
stainless-steel cable seal or drum seal, as thermoplastics can become brittle
at low temperatures.
bulk to bottled or tabletted final product, seals are used throughout to control and safeguard each step.
bulk materials that are supplied
in stainless steel tanks and road tankers, a cable seal or reusable
electronic seal is recommended to
secure inlet and outlet valves. The benefit of using a reusable electronic seal is that sensors
can be fitted to multiple
manhole lids or other valves
in series and will activate
the seal if opened, generating a time and date stamped opening event. Cable
seals or plastic seals used on each
manhole and outlet valve can be costly and create considerable waste.
Intermediate bulk containers (IBC),
in either stainless
steel or high-
density polyethylene HDPE, have sealable
inlet and outlet valves.
For this application, either two seals
(that can be numbered alike) or a
single extra-long seal, such as the Modulo 1 (that can be 2.8 meters or more in length),
can be used. Sometimes, the return cycle
of an IBC for refilling is governed by whether the seal on the top cap remains unopened, confirming that it
has not been filled with another material in the interim that could contaminate the next batch. In which
case, two seals would be called for.
and drums moulded
in HDPE can have a screw cap, where eyelets are aligned for sealing, or a
lid that is locked tight with a
galvanised slotted spring clamp for sealing. These different containers require a suitable seal to secure them. Unisto
offers a range of drum closures
and seals in plastic, metal
or a combination of
materials depending on the application and type of container being used. Kegs will normally require a
pull through seal with a narrow ribbon diameter. The Compact Seal with 2mm diameter ribbon is the most suitable for this application.
higher security applications or where
the pharmaceutical is to be stored at low temperature, a stainless-steel
cable seal would be more suitable or perhaps a galvanised clip seal with stainless steel sealing wire. The cable or wire diameter can
be as little as 1.2mm with a very
wide choice of length to suit the application required. Drums and kegs often require a polyethene liner that is usually sealed
with a numbered security
tie. Plastic security
ties can have integral spikes that grip the bag for greater
security. That may be fine for sacks of post but, for fine chemicals or pharmaceutical ingredients, spikes have the potential to perforate the bags potentially allowing contaminates to enter. Spike free seals should be specified for liner bag applications. For best results when
sealing a bag, please see step
by step images.
Bag seals can also be manufactured in
metal-detectable polypropylene which is ideal for food
industry applications where online
detectors are used to prevent any metal parts reaching the consumer
in the finished product.
Raw, bulk drug or vaccine components
require bulk handling and protection from contamination but,
once tabletted, bottled, in vial
or ampoule, it requires different
security treatment, now the security defence is against counterfeiting and theft.
consumer/end-user-packaged finished product will be in a branded carton within a wholesale bulk distribution
outer grouping carton. Usually,
anti-counterfeit measures are taken on the consumer packaging.
There are several measures that
pharma companies take but the most frequently used is serialisation, where a serial number with bar or matrix code
can trace the drug back to the point of manufacture and
beyond, to the constituent parts of the drug. The war against counterfeiting is ongoing and ever changing.New technology is helping but the draw of patent
drugs and medicines purchased at low
cost on the internet is extremely hard
to combat. The outer grouping carton can be
security sealed in several ways to
avoid theft or substitution.
Tamper evident void tape is used by several drug companies to seal the
carton. Any attempt to remove the tape reveals a VOID message in
thick adhesive residue left behind on the carton and in the
removed tape. The tape can also be
printed, branded, numbered and contain special UV sensitive inks to avoid any chance
An alternative to tape is a strapping seal that secures
polypropylene straps around the carton
at the crossing points, rendering the strapping tamper
evident. The Straplock Seal was developed for the
rollout of the Euro currency back in 2002, when large blocks
of notes were distributed to banks within
the eurozone and beyond. The blocks were shrink-wrapped, strapped, and sealed with Unisto Straplock.
Tamper evident VOID tape and/or Straplock
Seals can also be used to
secure shrink wrapped palletised cartons for additional security as well.
next step is the distribution itself by road in sealed
vans, trailers or freight containers. High value or
sensitive cargo is most often secured by a bolt or heavy
gauge cable seal which provides
a barrier to all but the most determined thief.
High security bolt seals are normally 12mm in diameter
and cable seals
have 5mm steel
One prominent pharmaceutical, biotech
and life science logistic specialist is Biocair. This is a firm that has an in depth
understanding of their
customers’ needs and the precise
handling and conditioning requirements of each load they carry. Biocair
has a fleet of branded
vans that have Unisto’s C2K Remote electronic reusable security seals permanently fitted
to the rear doors. The opening of the door activates
sensors that automatically generate a new seal number, verifying to customers the integrity of the load on arrival
at the delivery point.
The speed of global shipments in drug distribution and development is
of the essence and much use is made of airfreight containers (or unit load
devices). These are most often sealed with 1.5 to 2mm diameter cable seals although thin ribbon plastic pull-up seals
are also used to control
access to the container contents.
In conclusion, the care that will be needed
to ship consignments of such a vital and
brand-new vaccine around the globe and get it to local vaccination centres
will be immense.
At the beginning and end of each step of distribution, security
seals and temperature loggers will need to
be checked and recorded. A robust audit trail will be vital to ensure the smooth rollout that will build public
confidence and get this enormous
vaccination program done.