When it comes to precision-controlled environments, balancing performance and budget is often a challenge. A recent project delivered by Labworks put our expertise to the test: designing a -20°C controlled environment with tighter temperature stability than industry standards—all while staying within the client’s budget. Labworks could have proposed changing the design to a zero-deviation freezer (zero or negligible temperature spike during defrost) which is not uncommon in the industry but this would have been extremely costly. Given the ultimate product specification limits of ±5°C it would also have been unnecessary to provide a freezer that maintained less than +/-1C during defrost. The key through all of this was to meet our customers expectations without adding unnecessary costs or complexity.

Understanding the Challenge

The standard for this temperature-controlled Freezer allowed for a product deviation tolerance of ±5°C, but this particular client requested significantly stricter temperature control at ±3°C to stay within their pre-action alarm thresholds. This level of precision typically requires costly upgrades, making it difficult to stay within budget. Our goal was clear: develop a system that could deliver enhanced stability without adding unnecessary costs.

Our Solution: Engineering Excellence & Cost Efficiency

At Labworks, we believe that high-performance solutions shouldn’t come at the cost of financial feasibility. Our approach focused on:

• Optimizing refrigeration system components for better efficiency and reliability.
• Refining control mechanisms to maintain consistent temperatures.
• Maximizing energy efficiency to lower operational costs over time.
• Leveraging our industry expertise to design a system that exceeded the client’s expectations without exceeding their budget.

The Results: Outperforming Expectations

By implementing these strategies, Labworks International successfully delivered a solution (±2°C) to meet the customer requests (±3°C) and further exceed the Specification limits (±5°C)

The Impact: More Than Just Stability

Beyond achieving better-than-expected temperature control, our approach delivered additional benefits:

• Enhanced product protection with reduced temperature fluctuations.
• Increased energy efficiency leading to long-term cost savings.
• Budget-conscious execution ensuring the client stayed within financial limits.

Why This Matters

Achieving tighter temperature control in cold storage environments is critical for industries that rely on stability, such as pharmaceuticals, healthcare, and research. Labworks International’s ability to engineer cost-effective, high-precision solutions demonstrates that exceeding expectations doesn’t have to mean exceeding budget.

Conclusion: Precision Without Compromise

This project showcases Labworks International’s commitment to innovation, efficiency, and client success. By combining technical expertise with strategic cost management, we continue to set new standards in precision-controlled environments.

If your facility requires advanced environmental control solutions, contact Labworks International today to see how we can help optimize performance and deliver a solution that meets your needs.

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Hodess Cleanrooms, a leader in the cleanroom construction and advanced technology industry, announced today that it has acquired Labworks International based in Woodbridge, Ontario, Canada. This acquisition further strengthens Hodess Cleanrooms’ position as a full lifecycle partner, providing additional expertise to clients in transformative industries.

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The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global initiative that brings together regulatory authorities and pharmaceutical industry experts from around the world.

Its goal is to develop guidelines for pharmaceutical product development, registration, and post-approval. These guidelines cover various aspects of drug development, including quality, safety, efficacy, and multidisciplinary categories.

The Importance of ICH Guidelines

Global Alignment

While ICH guidelines are not mandatory regulations, they are widely accepted and recognized by regulatory bodies in many countries around the world.

One of the main advantages of ICH guidelines is their ability to promote harmonization of regulatory requirements among different parts of the globe. By providing a common framework, ICH guidelines streamline the registration of pharmaceutical products and facilitate global access to safe and effective medicine.

Quality Assurance

By providing standardized approaches to quality control, clinical trial design, safety assessment, and more, ICH guidelines help ensure that pharmaceutical products on the market meet high standards of quality, safety, and efficacy regardless of country of origin.

Efficiency and Cost Savings

Through establishing common principles and methodologies for drug development and regulation, ICH guidelines help smooth the drug development process and reduce costly regulatory barriers. This means cost savings for both the industry and regulatory agencies.

What is ICH stability testing?

ICH stability testing assesses how a drug product is affected by environmental factors such as temperature, humidity, and light.

According to ICH stability guidelines, there are three basic stability tests to ensure that pharmaceutical products remain safe and effective throughout their shelf life:

1. Physical and chemical integrity: This stability test centres on the physical properties of a substance, including colour, pH level, odour, and texture.
2. Microbiological stability: This test targets microorganisms and examines the level of bacterial and mould contamination.
3. Packaging stability: This test evaluates how the packaging system of the product affects the stability of the drug contained within it.

Why use ICH stability chambers?

At Labworks International, our ICH stability chambers provide the controlled environmental conditions necessary for conducting stability studies in compliance with ICH guidelines.

With precise control over temperature, humidity, light, and other environmental factors, our stability chambers are able to simulate various storage conditions and provide reliable data for researchers to assess the long-term stability of pharmaceutical products.

Our team is well-versed in ICH Q1A requirements and is ready to assist you in designing your trial protocol. We offer a complete range of stability chamber designs with flexible performance parameters to suit your project’s needs. From lighting options to data logging capabilities, we will work with you to customize the chamber to meet your needs.

Understanding ICH Stability Guidelines

The ICH stability testing guidelines provide recommendations on the design and conduct of stability studies to ensure that pharmaceutical products are safe, effective, and of acceptable quality throughout their shelf life.

Q1A (R2): Stability Testing of New Drug Substances and Products

This guideline outlines the general principles for the design of stability studies, defining the types of studies required, the length of those studies, sampling frequencies, and testing methods.

Q1B: Photostability Testing of New Drug Substances and Products

This guideline provides specific recommendations for evaluating the effects of light exposure on pharmaceuticals and details the procedures for testing photostability, including lighting conditions and test duration.

Q1C: Stability Testing for New Dosage Forms

Q1C targets the stability testing requirements for new dosage forms of existing drugs in the market, ensuring that their stability is maintained even with changes in formulation.

Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

This guideline describes the statistical approaches of bracketing and matrixing to reduce the number of stability tests required for different drug strengths, formulations, and packaging configurations.

Q1E: Stability Data Package for Registration Applications in Climatic Zones III and IV

This part of the ICH guidelines details the stability testing needs for products designed for climatic zones that have higher temperature and humidity levels.

ICH Storage and Stability Conditions for Testing

The ICH guidelines specify the ideal conditions for storing and conducting stability testing across three climate zones: the United States, Europe, and Japan. Here are the storage and stability conditions recommended by the ICH:

Long-Term Testing Conditions

Long-term testing evaluates a product’s stability over its proposed shelf life in the target market. For Zone I (temperate) and Zone II (subtropical with potential high humidity), this includes maintaining conditions at 25°C ± 2°C/60% RH ± 5% RH for 12 months or more and 30°C ± 2°C/65% RH ± 5% RH for 12 months or more, respectively.

Accelerated Testing Conditions

Accelerated testing assesses a product’s stability in a shorter time frame. Typical conditions for this type of testing are 40°C ± 2°C/75% RH ± 5% RH or 40°C ± 2°C/25% RH over six months.

Deviation from the recommended storage conditions may be accepted if the manufacturer can justify the adjustment based on product knowledge. Some potential reasons for altering the suggested storage parameters include alternative dosage forms or diverse product types such as biotechnological or biological drugs.

Choose Labworks International for Stability Chambers

Labworks International is the trusted stability chamber supplier in North America. We offer a range of fully customisable stability chambers that are designed to comply with FDA and Health Canada standards and ICH guidelines.

Our chambers are complete with stainless steel interiors and shelving, humidification, precise temperature control, light shelves, and more.

For more information about our stability chambers, speak to one of our team members today at 1-888-890-3334 or leave us a message here.

The post ICH Stability Guidelines: Ensuring Compliance and Quality in Pharmaceutical Storage Rooms appeared first on Labworks Blog.

Abstract

The refrigerated Hänel Lean-Lift® Vertical Lift Module (VLM) is a cutting-edge storage solution that provides efficient and organized storage while maintaining temperature control for sensitive materials. This white paper outlines the challenges faced during the development and installation of the refrigerated Hänel Lean-Lift® VLM system in a pharmaceutical plant in the US. It discusses the creative solutions devised to overcome these challenges, ensuring the redundancy of the refrigeration system, installation sequence, efficient air circulation, maintaining the temperature uniformity in the space, and reliable system operation.

Keywords: Controlled Environmental Rooms, High Density Storage, Temperature Mapping

Introduction

The refrigerated (+5°C ±3°C) Hänel Lean-Lift® VLM is a revolutionary storage system that integrates temperature control capabilities into the space-saving vertical storage solution. This white paper delves into the key challenges encountered during the project, emphasizing the technical and logistical complexities that needed to be addressed.

Challenges and Solutions

Next few paragraphs describe the challenges and implemented solutions.

1. Refrigeration System Redundancy and Space Limitation

The project required two independent refrigeration systems to minimize the downtime. However due to space constraints, placing two evaporator units in the room was not feasible. Labworks has come up with a creative solution to ensure redundancy and maintain temperature consistency. The solution involved employing a face-split coil configuration within a single evaporator casing, maximizing space utilization while ensuring reliable temperature control even in the event of a coil failure.

2. Installation Sequence

Installing the refrigerated Hänel Lean-Lift® in a confined space required careful consideration of the installation sequence. The optimal sequence involved constructing three walls, installing the evaporator unit, positioning the Lean-Lift® storage system, and then completing the installation with the front wall. This sequence allowed for efficient utilization of space and minimized disruptions during installation.  Front wall installation presented challenges due to batten strips (FM 4880 requirement) that required precise placement to ensure a secure fit. The solution involved meticulous pre-planning and alignment procedures, ensuring that the batten strips were seamlessly integrated to provide structural integrity and meet the requirements.

3. Air Circulation Within the Space:

Efficient air circulation was crucial to maintain uniform temperature distribution. The evaporator unit cooler was installed 26.5ft above floor, and in order to address the challenge of minimizing pressure drop and ensuring warm air’s return to the evaporator, deflectors were strategically placed to guide airflow. This solution not only maintained temperature uniformity but also enhanced energy efficiency. Figure 1 illustrates the effect of axial fans.

4. Maintaining Temperature Uniformity Through Hänel Lean-Lift®:

The solid shell design of the Hänel Lean-Lift® posed a challenge for air circulation. Computational Fluid Dynamics (CFD) simulations were employed to identify potential circulation issues and areas that need improvement. Subsequently, axial fans were strategically integrated to improve airflow within the system, ensuring consistent temperature control across all stored items. Figure 2 and 3 respectively depict the CFD result as well as the temperature mapping result, which stunningly all 25 probes are within ± 1°F.

Table 1 shows the min and max temperature during 24 hours temperature mapping.

5. Roll-Up Door Heights:

To facilitate both operation and maintenance, the roll-up door was designed to stop at two different heights. This solution allowed convenient access during routine operation and comprehensive access for maintenance and repair activities, enhancing the system’s user-friendliness and overall reliability.

6. Dual Redundancy on PLC:

Ensuring the system’s uninterrupted operation was paramount. To achieve this, a dual redundancy approach was implemented for the Programmable Logic Controller (PLC) and all input/output (I/O) cards. This redundancy ensured that in case of a failure, the backup PLC seamlessly takes over, minimizing downtime and maximizing system reliability.

Conclusion

The refrigerated Hänel Lean-Lift® project posed several intricate challenges, from optimizing coil configurations to ensuring efficient air circulation and maintaining system redundancy. Through creative solutions such as face-split coils, deflectors, axial fans, and running CFD calculation during the engineering phase, these challenges were successfully overcome, resulting in a highly efficient and reliable temperature-controlled storage solution. The successful implementation of these solutions showcases the importance of comprehensive planning, strategic problem-solving, and collaboration in tackling complex engineering projects.

Future Considerations

As technology continues to advance, future iterations of the refrigerated Hänel Lean-Lift® could incorporate predictive maintenance features, improved energy efficiency, and further automation to enhance the user experience and meet evolving industry standards.

References

Tables

About Hänel Storage Systems

Founded in Germany in 1953, Hänel’s North American headquarters has been located in Pittsburgh, PA since it was established in 1984.  Hänel Storage Systems specializes in the design and engineering of Rotomat® vertical storage carousels and Lean-Lift® Vertical Lift Modules for a wide range of industries and applications.  Hänel provides sales, service and technical support to North and South America through a network of factory-trained channel partners and service providers.

Introduced in 1957, the Rotomat® Vertical Carousel is based on the Ferris Wheel principal.  Inventory is stored in a series of carriers that rotate within an enclosed unit and are accessed at a single opening.  This vertical “goods to the user” concept improves productivity, lowers costs, increases security and saves valuable floor space.

Introduced in 1994, the Lean-Lift® Vertical Lift Module stores inventory on trays that are automatically measured for height each time they enter the unit. A vertical extractor places each tray within the unit in a location that maximizes available storage space.  Trays can be equipped with dividers, totes, bins and specialized holders to store any type of inventory.

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