TJPS Vol.41 (Supplement Issue) 2017

TJPS 2017, 41 (Supplement Issue): 113

Design of radio frequency identification (RFID) technology for raw material management in pharmaceutical manufacturing process

Jesdaporn Rachivong1, Anuchai Theeraroungchaisri2, Natapol Pornputtapong3, Weerayut Chirarutsami, Phanphen Wattanaarsakit1,*

1 Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University,

Bangkok 10330, Thailand 2 Department of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University,

Bangkok 10330, Thailand 3 Department of Biochemistry and Microbiology, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok

10330, Thailand * Corresponding author: Tel. +66(0)816175844; Fax. +66(0)22188279; E-mail address: aphanphe@chula.ac.th

Keywords: radio frequency identification, raw material management, pharmaceutical processing

Introduction During the past few decades, a large amount of interest has been placed on the pharmaceutical industry

sector. Manufacturing process plays an important role in producing high quality pharmaceutical products.

Management of active and inactive pharmaceutical ingredients during manufacturing process is also

significance in ensuring product quality. Generally, even a single batch production, various types and amount

of materials are used and transferred through various stages of the production line while excessive material are

return back to the inventory. Quality practices and guides have been applied to avoid contamination, cross-

contamination and mix-ups through the process [1]. Normally, an operation which complying with GMP could

encounter any problems such as incorrect determination regarding types and amount of materials,

miscommunication, inappropriate decision, delayed of work due to human error in operation. With appropriate

supporting identification technology, the problems mention above would likely be prevented. Radio frequency

identification (RFID) is a technology using radio frequency to automatically identify objects. RFID system is

mainly consists of readers and tags which communicate with each other via radio frequency. The technology

has the capability to identify an object identity, location, and condition. RFID has been developed and applied

in various areas of industry. As a flexible auto-identification technology, it can be used for tracking and

monitoring objects automatically with high accuracy. It also has numerous advantages such as contactless

usage, multiple tag read, higher data storage and product differentiate [2-9]. The aim of this study was to study

and design to integrate RFID technology into a part of raw material flow including receiving, inspection, and

dispensing in pharmaceutical manufacturing process.

Methods To integrate RFID technology into a part of raw material flow in pharmaceutical manufacturing process,

the following methodology was studied.

1. Study of process flow of raw materials

To understand raw material flow of which its activity related to production phase, the process was observed

at Government Pharmaceutical Organization manufacturing. The study has focused on flow of raw material in

warehouse, from material receiving and inspecting, and in separated weighing area for dispensing before

transfer to production line. Necessary information of the materials that should be carried within the process for

identifying, tracking and tracing back were also studied.

2. Study of RFID system and devices

RFID systems can be either combined with existing manufacturing information systems such as material

requirement planning (MRP) and enterprise resource planning (ERP) or customized to a specific process. The

devices composed of RFID readers and RFID tags and frequency range were compared while selecting the

most appropriate one for the design process.

Thai Journal of Pharmaceutical Sciences (TJPS) The JSPS-NRCT Follow-Up Seminar 2017 and

33rd International Annual Meeting in Pharmaceutical Sciences

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3. Conceptual design for RFID implementation

Conceptual design to integrate RFID technology in raw material process flow to improve the efficiency of

the process for identifying, tracking and tracing back as well as improving the effective of raw material FXFO.

Regulations and GMP requirement were concerned in the designed process.

4. Experimental design for RFID implementation

After process design and selection of the devices, experiments for system integrating test was designed.

4.1 Verification of the system and devices. Testing of the system and device are verified to confirm that

RFID device, system software and designed process are properly integrated.

4.2 Process flow test. Simulation of the test starts from warehouse by recording and tagging of raw material

received, after that the materials are quarantine until quality control (QC) department proof and release

them into warehouse. Continue with picking order, RFID reader can select the materials which was

released by QC department base on expiry date. The test can differentiate these materials precisely in

a short period of time. The materials are weighed and dispensed in new container with new tag

generated for updating of their quantity.

4.3 Identification of raw materials. After raw material dispensing, checking of all dispensed materials before

transferring to production line are tested. The test is using RFID reader scan those materials for identifying their

types and amount. The system efficiency test is also study with different items of raw materials at 5, 10 and 15

items and compare with manual checking. Identifying of material types and time consuming are discussed.

Results and discussion From observation at pharmaceutical manufacturing site, the flow of activities was started from material

receiving and moving to a quarantine area waiting for inspection and testing from quality control department.

Once positive result received, passed materials were released and transferred to inventory warehouse. If

negative result received, rejected materials were sent to rejected area. Following a picking order, the passed

materials were manually chosen by first expiry first out (FXFO) to a separated weighing area for dispensing. All

of dispensed materials were manually checked in term of type and amount according to the order before

transferring to a production line (figure 1). A process flow of raw materials was designed with GMP requirement

to support implementation of RFID technology (figure 2). The integrated flow which plugged in with RFID device

was focused on three modules including warehouse, dispensing and production (figure 2b). Begin with

warehouse module, the system could manage a process of raw material receiving. Information of raw material

received data such as material name, lot number, supplier code according to an approved vendor list, receiving

date, receiver name and expiry date, were recorded into RFID tag and carried within the process. Including data

test from QC analysis, status of material in the tag was re-recorded and changed to a passed material for

warehouse. All of the changed information was sent to a central database. In dispensing module, RFID reader

scanned materials on inventory shelf and automatically sort data and materials were chosen with designed

condition. New RFID tag was generated, with its own upstream data, and tagged on a new container of

dispensed materials then transferred to production line. Before starting of production line in last module, RFID

reader instantaneously scanned these dispensed materials to identify and checking if their types and amount

are right without time consuming. The reader can also track and trace back of those materials in the process.

The concept of process flow design with plugged in of RFID can support manufacturing process, improve

process efficiency and decrease human error.

Selection of RFID devices and frequencies were compared in table 1. RFID systems can operate in

either low frequency (LF, 125-135 kHz), high frequency (HF, 13.56 MHz) or ultrahigh frequency (UHF, 860-960

MHz). Pharmaceutical process and environmental condition also play a greater role in RFID system selection.

In the designed process, UHF is more appropriate than LF and HF. Even higher cost, UHF offers much better

read range, simultaneously and rapidly multiple tag reading, and can transfer data faster than LF and HF. RFID

reader, a device using radio waves to wirelessly transfer data with RFID software between itself and RFID tag,

can identify objects quicker, accurately and at various points in the process. In our process, a handheld reader

was more convenient to read and write in the proper length where a fixed reader type was not as it’s only apply

to a moving object and detected in a particular area with data transferred via computer. RFID tags, storing the

item information, were varied in term of frequency on which the system operated. An economical passive RFID

tags, with no internal power source and instead are powered by the electromagnetic energy transmitted from

an RFID reader, was preferred than an active tags with battery power. A signal from passive tag can be received

at reasonable distance in pharmaceutical process without interfering signals as emit from active tag. These

passive tags can be attached to objects in the process such as plastic drum, stainless vessel tank, trolley and

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pallet. Either combined RFID software with MRP/ERP or customized to a specific process, data can be

processed by on-line or batch-file mode. On-line mode, a handheld reader itself can process data by using the

same database as in computer (figure 3, left). Batch-file mode, a handheld reader itself cannot process data,

only transferred data to computer for data processing (figure 3, right). RFID software with on-line mode, more

convenience, would be preferred as can be used with mobile phone.

From the designed study, the raw material management process flow was integrated with RFID

technology including the designed experiment. RFID devices were plugged in the process with practically work.

The system could control, track and trace of raw material throughout the processing with less time consuming

and complying with GMP.

Figure 1 Basic raw material management process

Figure 2 Design of raw material process flow (a) and Design of raw material process flow integrated with RFID (b).

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Figure 3 RFID software diagram: On-line mode (left) and Batch-file mode (right).

Table 1 RFID system and device selection.

Conclusion RFID technology has potential using to support raw material management, track and trace back of materials to

ensure compliance with GMP in pharmaceutical manufacturing.

Acknowledgements The authors would like to thank Chulalongkorn University Graduate School Thesis Grant and

Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn

University for providing research facilities. We also thank to Government Pharmaceutical Organization and

Smart Identify Ltd., for helpful supporting this study.

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