creating a transfer solution
TRANSCRIPT
Applying the Doverpac Drum Transfer System
Creating ATransfer Solution
One of the simplest, most convenient and most cost-effective ways to ship, receive,
and store bulk powder ingredients, including active pharmaceutical ingredients
(APIs), intermediates, excipients, and ingredients for buffers and media, is in drums.
The contents of these will need to be transferred before use, and this process can be
challenging. Integrated drum transfer solutions make the process simpler, cleaner,
and faster, improving safety for both workers and patients, as well as protecting any
remaining ingredients for storage.
The Challenges Of Drum TransferA great many powder ingredients for pharmaceutical manufacturing are delivered
in large drums, from media ingredients to the APIs themselves. The ingredients
then need to be taken out of the drums and transferred into other containers for the
next step in their use – this includes:
Milling — sifting or particle size reduction
Subdividing — dividing into measured amounts
Repackaging — for customer use
Charging —– transferring to vessels for the next step of processing
Whatever the application for powder transfer, the fi rst challenge faced is handling
the drums. Full drums can be very heavy to lift, and may need to be lifted high
to charge containers or equipment. Unless drums are handled carefully, this puts
workers at risk of injury. Manual handling can also be a slow process, which can
cause delays.
Once the drums are opened, the next challenge is containing the spread of powder
and avoiding contamination. Transferring powder from one container to another
without containment, whether by pouring or scooping, can create plumes of dust.
This may settle on surfaces, including other drums, bags, and packages, and
could cause cross-contamination with other products manufactured in the same
facility. To avoid putting patients at risk from side effects or allergic reactions, areas
where powders are handled will need regular cleaning. Any spills can also lead
to cross-contamination, and could waste expensive ingredients, thereby increasing
production costs and creating challenges for inventory reconciliation.
Dust in the air puts workers at risk, as even inert powders, when inhaled, can
cause lung damage, and active ingredients can cause lung, skin, and eye irritation
or damage, or trigger allergic reactions. Companies transferring materials from
drums need to ensure that their containment levels are within national and regional
exposure limits. These will differ according to the content of the drums; for
example, the exposure levels may be for dust for inert buffers and media, and
for toxicity limits for APIs, such as cytotoxics.
Processes may only use part of a drum of powder, and to avoid waste, members
of staff need to be able to return excess powder to the container, seal the drum,
and remove it from the transfer area without affecting the product’s purity.
Creating SolutionsOptions for solving powder containment issues need to transfer
the ingredients from the drums to the applications effi ciently
and cost-effectively without compromising safety. The
options can be divided into open processing and closed
processing approaches.
Open processing approaches
In an open processing suite, the workers are protected
from powder during drum transfer by wearing personal
protective equipment (PPE), and overall contamination
levels are reduced by using air extraction. However, in
open processing systems, powders can still get into
the air and so the whole of the processing suite requires
regular deep cleaning. Open processing does not reach
the ISPE Containment Community of Practice’s Risk
Based Manufacture of Pharmaceutical Products (Risk-
MaPP) guidelines for manufacturing hazardous compounds.
Closed processing approaches
Closed processing approaches are more effective than open
approaches at containing powders during transfer from the drum,
reducing cross-contamination and allowing manufacturers to meet
cGMP guidelines. One approach is to use a rigid isolator with panels for
operator access, airlocks, and transfer ports. However, their rigid design can
cause ergonomic issues for workers who are shorter or taller than average. Rigid
isolators can be costly to set up and run — the capital outlay is high, and they
need regular cleaning. If needs change or technologies advance, rigid isolators
are diffi cult to adapt or retrofi t.
Disposable single use isolators provide a greater degree of adaptability in set
up and use. The capital investment and cleaning costs are much lower, and
fer
y
en
drum,
to meet
th panels for
Open processing
does not reach the ISPE Containment
Community of Practice’s Risk Based Manufacture of Pharmaceutical Products (Risk-MaPP) guidelines
for manufacturing hazardous
compounds.
validation is quicker, as the system uses single-use consumables that can be disposed
of after use. The nature of single use items is that they are fl exible, improving the
ergonomics over rigid isolators and making it easier to create seals and connections
between different pieces of equipment. If changes in processes are needed, for
example, production levels go up or down, the required levels of stringency change, or if
a production line created for one product needs to be used
for another one because of project failures or changes
in scheduling, changing the single use enclosures and
bags is a simple process, and may not even need to be
revalidated. Single use systems are also generally easier
to use than rigid systems, so the error rates are lower and
there is less need for time-consuming training.
Using a drum transfer system
While both rigid and single use isolators contain the
powder, protect workers, and reduce the risk of cross-
contamination, they do not necessarily meet the fi rst
challenge, that of handling the heavy drums. ILC Dover’s
drum transfer system has been created to have all the
advantages of single use products, with the added
capability of lifting the drum into place.
The system is made up of a drum enclosure frame
and drum lifter, with options for a variety of different
single use modules, including fl exible enclosures that
can allow operator access, drum sleeves linking the drum to the rest of the system,
attachment rings providing secure connections, and a number of different outlets and
transfer sleeves. The drum is connected via disposable drum sleeves and lifted into
place. The outlet sleeve connects to process equipment such as vessels or mills via a
transfer sleeve, or links directly to DoverPacs, allowing completely contained transfer
of product, protecting workers, and reducing product loss. Any excess powder remains
in the drum and can be sealed using the drum liner, ensuring that it remains clean for
its next use.
ILC Dover’s system is completely modular so it can be adapted to existing processes
and equipment, for example, the O-ring canister (see Figure 1 and Figure 2) designed
to introduce the drum to the enclosure is patented and is standard throughout the
company’s product range. The fi lm used for the single use modules is specifi cally
designed to meet the product contact regulations in the regulatory guidelines. It’s also
Figure 1: ILC Dover’s patented O-ring canisteras used on a drum transfer system
One of the applications for the ILC Dover drum transfer system is in the charging of vessels for the next step of cGMP (current good manufacturing practice) processing (see Figure 3 and Figure 4). This application uses ILC Dover’s disposable conical transfer sleeve to connect the drum transfer system and the process vessel. The sleeve is able to connect securely with standard process equipment and vessels, and incorporates the DoverLoc, a molded clamp that secures the liner where it connects to the drum, minimizing cleaning.
For a clean and secure transfer of powders from the drum to the process vessel:Remove the drum lidOpen the inner drum liner Attach the liner Position the stainless steel cone on the drumlifter over the drumPull the liner through the cone and attach it with a clamp on the coneInvert the drum and attach the drum transfer liner to the vessel nozzleOpen the clamp to allow gravity feed of the powder into the vessel for processing
In containment verifi cation studies of the ILC Dover drum transfer station, the test results showed that the system was able to provide containment of powders below the target concentration of 1.0 μg/m3 when transferring powder from a drum to a vessel.
Case study:Charging to vessels
Figure 3: Inlet and outlet
Figure 4: Reactor charge using drum transfer system
robust, fl exible, and highly transparent, which means that
it can be lowered or raised as required for ergonomics, and
labels and scales remain clearly visible.
Because the frame is lightweight and portable, it can
be moved from place to place, reducing the need for
duplication of equipment. It can even be folded up and
stored away as required, allowing cost-effective use of
valuable space.
ILC Dover’s drum transfer system has been validated
through its real-world use in a range of customer processes
involving contained transfer of materials from drums to
pharmaceutical applications. The company also provides
engineering and service support, including training for
operators.
About DoverPac® Containment SystemsDoverPac® Containment Systems, an ILC Dover brand, is the global pioneer
of disposable process and powder containment systems. Launched from a
partnership with multi-national pharmaceutical companies to develop high
containment for API production and oral solid dosage processing, DoverPac®
is the global standard for containment, reliability, and service. We’ve been
providing proven Flexible Containment solutions since 1997 and have over
300,000 installed to date. ILC Dover has state-of-the-art manufacturing facilities
dedicated to the production of the DoverPac® line including custom designed
sealing equipment capable of producing reliable 3D and 2D heat seals, and an
ISO Class 7 Clean Room. A staff of experienced design engineers permits us
to customize products and create systems to fi t your needs while optimizing
worker ergonomics and productivity. Decades of work with NASA give us the
experience to provide the detailed documentation packages, critical quality
data, and certifi cations required.
Figure 2: Close-up ofILC Dover’s O-ring canister
Figure 2: Close-up ofILC Dover’s O-ring canister
To correspond directly with the author contact:Chris Rombach
Biopharm Product Manager302-335-3911 x792
ILC Doverwww.doverpac.com