Brevetti CEA engineers and builds simple, well-built solutions focused on inspecting
vials, ampoules, cartridges and syringes to ensure all foreign materials are detected
and those units are removed from the supply chain.
freeze-dried products. Brevetti CEA engineers
and builds simple, well-built solutions focused
on inspecting vials, ampoules, cartridges and
syringes to ensure all foreign materials are
detected and those units are removed from the
supply chain. They customize lighting units to
successfully inspect your product through reflection, absorption and/or polarization utilizing
both intermittent and continuous motion
INCORPORATING SERIALIZATION PROGRAMS
The requirement to integrate and establish
serialization programs has also provided new challenges to pharmaceutical manufacturers. Considering the increasing threat
of counterfeit, misbranded, adulterate and/or diverted prescription
drugs, reliable track and trace procedures must be employed to ensure
consumer safety. In theory, serialization is a straightforward process in
which a unique identifying code is applied to each unit-level product.
Codes are communicated along the packaging line to allow for aggregation. Aggregation applies the parent-child relationship between the
unit-level product and cases and pallets in which they are shipped. This
information is then relayed through the supply chain to the end user.
With the increasing demand of serialization and many questions surrounding the upcoming regulations, manufacturers look to equipment
vendors for expertise on when, where and how to implement serialization on their existing packaging lines. IMA Life facilitates the best
approach for a phased, long-term, cost-effective, and sustainable program to suit your needs. They provide a variety of automatic labelling
equipment for easy application in existing carton and bottle packaging
lines. IMA offers small footprint options for existing lines where space
constraints are a serious issue.
As manufacturers prepare to install new packaging lines for new or
existing products, Serialization must be factored in to the overall design,
cost and timeline. Manufacturers develop their serialization strategy
based on regulations, including the proper unit dose required for serialized data and how far down the packaging line to aggregate products.
DIVIDELLA executes projects globally integrating serialization technology into new parenteral packaging lines. They create a system which
codes, verifies and tracks packages through the packaging process based
on clients’ serialization strategy. In addition, they collect and maintain
integrity of data through the supply chain.
Space limitations of new or existing lines must be considered when
integrating the additional equipment required for serialization. OCS
Checkweighers offers an integrated system to print, verify and inspect
products with their Traceable Quality System (TQS) equipment, comb-
ing the functions of three separate pieces of equipment into one, uti-
lizing one control software and interface. OCS is able to integrate third
party hardware and software specified by the client or provides a turn-
key solution complete with cameras, hardware and software. Human
readable text and 2D codes are gathered from the ERP infrastructure
(i.e. SAP, Oracle) and printed on the unit level package. The code and
text are verified by cameras. Inspection of the package is complete when
the package passes over the weigh cell, verifying product is present and
within weight tolerance.
Aggregation of the unit level product allows for traceability when
pharmaceuticals are distributed in shippers. It provides a parent-child
relationship between the unit level package the shipper. Secure aggrega-
tion must be achieved and accomplished by creating physical aggrega-
tion prior to data aggregation. Products must be bundled, and then the
barcodes are read and reported to the ERP System and printed on the
shipper label. This approach provides certainty that the physical con-
tents of the shipper match the information in the serialized database.
Based on manufacturers’ processing rates fully automated and semi-au-
tomated equipment is available through Optel Vision. The semi-auto-
matic aggregation station allows for manual packing of shippers and
utilizes a single layer reading station which relays the information to
a label printer. Labels are manually applied to the closed shipper after
secure aggregation is complete. In the even RFID is used at the shipper
level, Optel Vision offers an RFI Tunnel that identifies packages in a case
and links the shipper serial number with the items enclosed.
Achieving accurate serialized data and aggregation hinges on the automated equipment to communicate with existing ERP systems. Installed
Systech Citadel systems facilitate accurate data exchange and storage of
serialization and aggregation data through the supply chain. Systech provides both software and hardware to achieve accurate serialization.
By employing these inspection technologies to new and existing packaging lines, manufacturers can guarantee products received by end users
have been inspected for filling and packaging defects creating safer pharmaceuticals worldwide. To also provide security that patients receive
authentic, non-counterfeit, unadulterated products as we enter the time
where serialization becomes mandated, it is imperative to understand
the technologies offered to achieve serialization and aggregation as they
are interpreted implemented and by your company.
18 FEBRUARY 2014 ◗ pharmpro.com
INSPECTION & PACKAGING TECHNOLOGIES