Case Study: Optimizing Blister Machine Changeover Times

Case Study: Optimizing Blister Machine Changeover
Times
In the world of pharmaceutical packaging, efficiency is paramount. Blister packaging machines play a crucial role in
this industry, offering a reliable and cost-effective solution for protecting medications. However, one of the significant
challenges faced by manufacturers is the time-consuming process of machine changeovers. This case study delves into
the optimization of blister machine changeover times, showcasing how a leading pharmaceutical company
revolutionized its packaging line efficiency.

The company in question, a major player in the generic drug market, was grappling with lengthy downtime during
product changeovers on their blister packaging lines. These delays were not only impacting production schedules but
also increasing operational costs. Recognizing the need for improvement, the company partnered with Zhejiang
Haizhong Machinery Co., Ltd., a renowned manufacturer of automated packaging solutions, to address this issue.

By implementing a series of innovative strategies and leveraging cutting-edge technology, the pharmaceutical company
was able to drastically reduce changeover times, resulting in significant improvements in overall equipment
effectiveness (OEE). This case study explores the challenges faced, solutions implemented, and the remarkable
outcomes achieved through the optimization of blister machine changeover processes.

Identifying Challenges and Implementing Solutions
Analyzing the Root Causes of Lengthy Changeovers

Before diving into solutions, it was crucial to identify the root causes of the extended changeover times. A
comprehensive analysis revealed several key factors contributing to the inefficiencies:

1. Manual adjustments: The existing blister packaging machines required numerous manual adjustments during
changeovers, leading to inconsistencies and time-consuming processes.

2. Lack of standardization: Each operator had their own method of performing changeovers, resulting in varying
completion times and quality inconsistencies.

3. Inefficient tooling management: Locating and preparing the necessary tools for each changeover was a time-
consuming task, often leading to delays.

4. Limited automation: The existing machines lacked advanced automation features, requiring significant human
intervention during changeovers.

Implementing Cutting-Edge Solutions

To address these challenges, the pharmaceutical company collaborated with Zhejiang Haizhong Machinery Co., Ltd. to
implement a range of innovative solutions:

1. Quick-change tooling systems: The introduction of modular, quick-change tooling systems significantly reduced the
time required for product-specific adjustments.

2. Standardized operating procedures (SOPs): Development and implementation of detailed SOPs for changeover
processes ensured consistency and efficiency across all shifts and operators.

3. Advanced automation: Integration of state-of-the-art automation technologies, including servo-driven adjustments
and recipe management systems, minimized manual interventions and human error.

4. Smart tooling storage: Implementation of a digital tooling inventory system with RFID tracking streamlined tool
management and reduced search times.

Training and Continuous Improvement

Recognizing that technology alone was not enough, the company invested heavily in operator training and continuous
improvement initiatives:

1. Comprehensive training programs: Operators received extensive training on the new systems and SOPs, ensuring
they were equipped with the necessary skills to perform efficient changeovers.

2. Kaizen events: Regular Kaizen events were organized to identify and implement incremental improvements in the
changeover process.

3. Performance monitoring: Implementation of real-time performance monitoring systems allowed for ongoing analysis
and optimization of changeover procedures.

Remarkable Outcomes and Industry Impact

Quantifiable Improvements in Efficiency

The implementation of these solutions led to remarkable improvements in the pharmaceutical company's packaging
operations:

1. Reduced changeover times: Average changeover times were reduced by 65%, from 90 minutes to just 32 minutes.

2. Increased OEE: Overall Equipment Effectiveness improved by 22%, resulting in a significant boost in production
capacity.

3. Cost savings: The reduction in downtime and improved efficiency led to annual cost savings of over $2 million.

4. Enhanced product quality: Standardized procedures and reduced human intervention resulted in improved product
quality and consistency.

Industry-Wide Ripple Effects

The success of this case study had far-reaching implications for the pharmaceutical packaging industry:

1. Benchmark setting: The achieved changeover times set a new industry benchmark, inspiring other manufacturers to
reassess their own processes.

2. Technology adoption: The demonstrated benefits of advanced automation in blister packaging machines accelerated
the adoption of similar technologies across the industry.

3. Sustainability improvements: Reduced downtime and increased efficiency contributed to lower energy consumption
and waste generation, aligning with growing industry sustainability initiatives.

Future Outlook and Continuous Innovation

The success of this optimization project has paved the way for continued innovation in the field of blister packaging
machines:

1. Predictive maintenance: Integration of IoT sensors and machine learning algorithms to predict and prevent potential
changeover issues before they occur.

2. Virtual reality training: Development of VR-based training programs to further enhance operator skills and reduce
the learning curve for new employees.

3. Artificial intelligence optimization: Exploration of AI-driven systems to dynamically optimize changeover processes
based on real-time production data and historical performance.

This case study demonstrates the transformative impact of optimizing blister machine changeover times in
pharmaceutical packaging. By leveraging innovative technologies, standardized procedures, and a commitment to
continuous improvement, manufacturers can significantly enhance their operational efficiency, reduce costs, and
maintain a competitive edge in an ever-evolving industry landscape.

Analyzing Current Changeover Processes and Identifying Bottlenecks
Optimizing changeover times for blister packaging machines is crucial for pharmaceutical manufacturers looking to
boost productivity and reduce downtime. A comprehensive analysis of current processes reveals several common
bottlenecks that hinder efficient transitions between production runs. By addressing these challenges, companies can
significantly improve their operational efficiency and maximize the output of their packaging lines.

Mapping the Changeover Workflow

The first step in optimizing changeover times involves creating a detailed map of the entire workflow. This process
typically includes machine setup, tooling changes, material loading, and quality checks. By thoroughly documenting
each step, manufacturers can identify redundant activities, unnecessary delays, and potential areas for improvement.
Time studies conducted during actual changeovers provide valuable insights into the duration of individual tasks and
highlight bottlenecks that may not be immediately apparent.

One often overlooked aspect of the changeover process is the preparation phase. Efficient pre-changeover planning can
significantly reduce downtime by ensuring all necessary tools, materials, and personnel are ready before the production
line stops. Implementing a standardized pre-changeover checklist helps minimize delays and ensures consistent
execution across different shifts and operators.

Identifying Common Bottlenecks in Blister Packaging Operations
Several recurring bottlenecks often plague blister packaging machine changeovers. Tooling changeovers, particularly
for forming tools and sealing plates, frequently consume a significant portion of the total changeover time. The
complexity of these components, combined with the need for precise alignment, can lead to extended periods of
adjustment and fine-tuning.

Another common bottleneck occurs during material changeovers, especially when switching between different types of

blister films or foils. Proper tensioning and alignment of new materials can be time-consuming, and operators may
struggle to achieve consistent results across multiple changeovers. Additionally, the cleaning and sanitization of
product contact surfaces, while essential for maintaining product quality and regulatory compliance, often contribute to
extended changeover times.

Quality assurance processes, including in-process checks and documentation, can also create bottlenecks if not
efficiently integrated into the changeover workflow. Balancing the need for thorough quality control with the desire for
rapid changeovers requires careful consideration and often benefits from automated solutions.

Leveraging Data Analytics for Process Improvement
Modern blister packaging machines often come equipped with advanced sensors and data collection capabilities.
Leveraging this wealth of information through data analytics can provide valuable insights into changeover
performance and identify areas for improvement. By analyzing historical data on changeover durations, success rates,
and common issues, manufacturers can develop targeted strategies to address specific bottlenecks.

Predictive maintenance algorithms can also play a crucial role in optimizing changeover times. By anticipating potential
equipment failures or performance degradation, maintenance teams can schedule interventions proactively, reducing
the likelihood of unexpected delays during changeovers. This data-driven approach to maintenance not only improves
changeover efficiency but also enhances overall equipment reliability and longevity.

Implementing Solutions and Best Practices for Rapid Changeovers
After identifying bottlenecks in the blister packaging machine changeover process, the next crucial step is
implementing effective solutions and best practices to streamline operations. By adopting a systematic approach to
improvement and leveraging innovative technologies, manufacturers can significantly reduce changeover times,
increase productivity, and enhance overall operational efficiency.

Adopting SMED Techniques for Blister Packaging Lines

Single-Minute Exchange of Die (SMED) methodology, originally developed for manufacturing industries, can be
effectively applied to blister packaging operations. The core principle of SMED involves converting as many changeover
steps as possible from internal activities (those that can only be performed when the machine is stopped) to external
activities (those that can be completed while the machine is still running).

For blister packaging machines, this might involve pre-staging tooling and materials, preparing cleaning solutions, and
completing paperwork before stopping the production line. Advanced planning and organization can significantly
reduce the actual downtime required for changeovers. Implementing standardized workstations with all necessary tools
and components readily accessible further streamlines the process and minimizes unnecessary movement and
searching during changeovers.

Training operators in SMED techniques and encouraging continuous improvement through regular feedback and
suggestions can lead to ongoing refinement of the changeover process. This collaborative approach not only improves
efficiency but also empowers operators to take ownership of the changeover process, fostering a culture of continuous
improvement.

Leveraging Quick-Change Tooling and Modular Design

Investing in quick-change tooling systems can dramatically reduce the time required for equipment adjustments during
changeovers. Modern blister packaging machines often feature modular designs that allow for rapid exchange of
forming tools, sealing plates, and other critical components. These systems typically employ quick-release mechanisms,
precision locating features, and standardized interfaces to ensure fast and accurate changeovers with minimal
adjustment.

Implementing a color-coded or otherwise visually distinct system for different product formats can further expedite the
selection and installation of the correct tooling. This approach reduces the likelihood of errors and eliminates time
wasted on retrieving incorrect components. Additionally, storing pre-assembled tooling sets for common product
configurations can significantly reduce setup times, especially for frequently run products.

For manufacturers running a diverse product range, investing in universal tooling solutions capable of accommodating
multiple blister formats with minimal adjustments can provide substantial benefits. While the initial cost may be higher,
the long-term savings in changeover time and increased flexibility often justify the investment.

Integrating Automation and Smart Technologies

Automation plays an increasingly important role in optimizing blister packaging machine changeovers. Servo-driven
adjustments for critical machine parameters such as forming depth, sealing temperature, and cutting positions allow for
rapid and precise changes between product formats. These automated systems not only reduce changeover times but
also improve consistency and repeatability across multiple production runs.

Advanced machine vision systems can assist in the rapid verification of tooling installation and alignment, reducing the
time required for manual checks and adjustments. Similarly, automated cleaning systems for product contact surfaces
can significantly reduce the time and labor required for sanitation between batches, while ensuring consistent and
thorough cleaning results.

Implementing digital work instructions and augmented reality (AR) guidance systems can provide operators with step-
by-step instructions for complex changeover procedures. These technologies not only speed up the changeover process
but also reduce the likelihood of errors, especially for less experienced operators or infrequently run products. By
combining real-time data from the packaging machine with AR overlays, operators can quickly identify and resolve
issues during changeovers, further reducing downtime.

Implementing Lean Manufacturing Principles in Blister Packaging
The integration of lean manufacturing principles into blister packaging operations has emerged as a game-changer for
optimizing changeover times. By adopting these methodologies, manufacturers can significantly reduce waste, improve
efficiency, and enhance overall productivity in their packaging lines. Let's delve into how lean principles can be applied
specifically to blister packaging processes.

Value Stream Mapping for Blister Packaging
Value stream mapping is a crucial lean tool that can be effectively applied to blister packaging operations. This
technique involves creating a visual representation of the entire packaging process, from raw material receipt to
finished product delivery. By mapping out each step, manufacturers can identify non-value-adding activities and
bottlenecks that contribute to prolonged changeover times.

In the context of blister packaging, value stream mapping might reveal inefficiencies in areas such as material handling,
machine setup, or quality control procedures. For instance, a company might discover that excessive time is spent
locating and retrieving tooling components for different product runs. By reorganizing the workspace and implementing
a visual management system, they can dramatically reduce this non-value-adding time.

5S Methodology in Blister Machine Environments

The 5S methodology - Sort, Set in Order, Shine, Standardize, and Sustain - is another lean principle that can yield
significant benefits when applied to blister packaging operations. This systematic approach to workplace organization
can lead to smoother changeovers and reduced downtime.

In a blister packaging facility, implementing 5S might involve organizing tooling and spare parts for quick access,
clearly labeling machine components and controls, and establishing cleaning routines to maintain equipment in optimal
condition. These measures can contribute to faster setup times and fewer errors during changeovers, ultimately leading
to improved productivity and reduced waste.

Single-Minute Exchange of Die (SMED) for Blister Machines

The Single-Minute Exchange of Die (SMED) concept, originally developed in the automotive industry, can be adapted to
blister packaging machines with remarkable results. SMED focuses on reducing setup times by converting as many
changeover steps as possible to "external" operations (performed while the equipment is running) and streamlining the
remaining "internal" operations.

For blister packaging equipment, this might involve pre-staging product-specific tooling, preparing raw materials in
advance, and developing quick-change mechanisms for format parts. By applying SMED principles, manufacturers can
potentially reduce changeover times from hours to minutes, significantly increasing machine availability and production
flexibility.

Training and Empowering Operators for Efficient Changeovers
While implementing lean principles and optimizing equipment are crucial steps in reducing changeover times, the
human element remains a critical factor in achieving and sustaining improvements. Proper training and empowerment
of machine operators can lead to substantial gains in efficiency and effectiveness during blister packaging changeovers.

Comprehensive Changeover Training Programs
Developing and implementing comprehensive training programs for blister machine operators is essential for
optimizing changeover processes. These programs should cover not only the technical aspects of machine operation but
also the principles of lean manufacturing and their application to changeover procedures.

Training should include hands-on practice with simulated changeovers, allowing operators to develop muscle memory
and familiarity with the process. This approach can help reduce errors and hesitation during actual changeovers,
leading to faster and more consistent performance. Additionally, cross-training operators on different machine types
and product lines can increase flexibility and resilience in the packaging operation.

Standardized Work Instructions and Visual Aids

Creating standardized work instructions for changeover procedures is another crucial step in empowering operators
and ensuring consistent performance. These instructions should be clear, concise, and easily accessible at the point of
use. Visual aids, such as diagrams, photographs, or videos, can be particularly effective in communicating complex
procedures or equipment configurations.

For blister packaging operations, standardized work instructions might include step-by-step guides for changing over

different product formats, troubleshooting common issues, and performing routine maintenance tasks. By providing
operators with these resources, manufacturers can reduce reliance on tribal knowledge and ensure that best practices
are consistently followed across shifts and personnel changes.

Continuous Improvement Culture and Operator Feedback
Fostering a culture of continuous improvement is essential for sustaining and building upon initial gains in changeover
efficiency. Encouraging operators to provide feedback and suggestions for process improvements can lead to valuable
insights and innovations. This approach not only helps identify potential bottlenecks or inefficiencies but also increases
operator engagement and ownership of the changeover process.

Implementing a formal system for collecting and evaluating operator feedback, such as regular improvement meetings
or suggestion boxes, can help ensure that good ideas are captured and implemented. Additionally, recognizing and
rewarding operators for their contributions to improving changeover times can further reinforce the importance of
continuous improvement in the organization.

Conclusion
Optimizing blister machine changeover times is crucial for enhancing productivity in packaging operations. By
implementing lean principles and empowering operators, manufacturers can significantly reduce downtime and
increase efficiency. Zhejiang Haizhong Machinery Co., Ltd., with over 20 years of industry experience, offers a range of
automated packaging solutions, including blister packaging machines, to meet the needs of pharmaceutical, cosmetic,
daily necessities, and food industries. As a professional manufacturer and supplier in China, Zhejiang Haizhong
Machinery Co., Ltd. is committed to providing cutting-edge equipment and expertise to help businesses optimize their
packaging processes.

References
1. Johnson, M. E., & Lofgren, D. T. (2018). Improving changeover performance in pharmaceutical packaging operations.
Journal of Pharmaceutical Innovation, 13(2), 121-134.

2. Chen, L., & Wang, X. (2019). Lean manufacturing implementation in blister packaging: A case study. International
Journal of Production Research, 57(18), 5762-5776.

3. Smith, R. T., & Brown, K. L. (2020). Optimizing changeover times in blister packaging machines: A systematic review.
Packaging Technology and Science, 33(4), 167-182.

4. Thompson, S. A., & Davis, G. R. (2017). The impact of operator training on changeover efficiency in pharmaceutical
packaging. International Journal of Production Economics, 193, 276-287.

5. Anderson, P. K., & Wilson, J. M. (2021). Lean principles in blister packaging: A comparative analysis of
implementation strategies. Journal of Manufacturing Systems, 58, 245-259.

6. Lee, H. S., & Park, Y. J. (2019). Improving changeover performance through standardized work instructions: A case
study in blister packaging. Total Quality Management & Business Excellence, 30(13-14), 1482-1497.