Precision Temperature Monitoring for Quality, Compliance, and Competitive Advantage

Discover Sunshine Corporation’s validated Temperature Monitoring System (TMS) for pharmaceutical coating. Powered by non-contact IR sensors and TempLogger software, it ensures precision, compliance with 21 CFR Part 11/GAMP 5, real-time alarms, robust audit trails, and validated performance (DQ, IQ, OQ, PQ). 

Introduction: Why Temperature Control is the Silent Guardian of Pharma Manufacturing

In pharmaceutical manufacturing, the smallest deviation can cause the largest consequences. Whether it’s coating tablets or encapsulating APIs, temperature isn’t just another variable—it’s the invisible thread holding product quality, patient safety, and regulatory compliance together.

For coating processes, in particular, temperature is a make-or-break parameter. Too high, and active pharmaceutical ingredients (APIs) degrade. Too low, and coating uniformity is lost. Either way, the result is wasted batches, compromised drug stability, and expensive rework.

That’s why precision temperature monitoring is a regulatory expectation, a quality assurance necessity, and a competitive advantage. Sunshine Corporation has taken this challenge head-on with its Temperature Monitoring System (TMS) powered by CPTLoggerV20 software.

This article merges technical insights, industry perspectives, and validation frameworks from practical viewpoints to show how Sunshine’s TMS transforms pharmaceutical coating from an error-prone process into a validated, audit-ready, and future-proof operation.

The Imperative of Precision: Regulatory and Operational Pressures

The pharmaceutical ecosystem is governed by stringent regulations such as:

• Good Manufacturing Practices (GMP) – demanding strict environmental and process controls.

• 21 CFR Part 11 – requiring electronic records and signatures that are secure, traceable, and tamper-proof.

• GAMP 5 – setting guidelines for validated computer systems.

Two Key Processes in Tablet / Film Coating

• Spraying: During spraying, tablets are tumbled in the coating pan as the coating solution is atomized and sprayed, focusing primarily on solution delivery parameters such as spray rate, nozzle pressure, and droplet size.

• Drying: The drying process follows, where heated air evaporates the solvent or water from the coated tablets, causing the film to solidify and adhere; at this stage, the tablet bed temperature becomes a critical process parameter because it directly influences film uniformity, adhesion, dissolution profile, and appearance.

Temperature logging begins at the drying phase when tablets are in motion and heated air is introduced, providing essential data for process validation, quality control, and GMP compliance. According to ICH Q8 guidelines, FDA and EMA GMP requirements, and key pharmaceutical references, tablet bed temperature during drying is the critical variable governing solvent evaporation and polymer film formation, making the monitoring and validation of drying-related temperatures—such as tablet bed temperature—mandatory for ensuring coating quality. 

In coating rooms, these frameworks converge on one key requirement: precise and documented temperature control. Without it, manufacturers face:

• Batch Rejection: Variations in coating thickness compromise dissolution profiles.

• Regulatory Non-Compliance: Incomplete or unverifiable audit trails.

• Product Instability: Reduced shelf-life and increased risk of recalls.

• Operational Inefficiency: Manual monitoring that is labor-intensive, reactive, and prone to error.

In this high-stakes environment, advanced temperature monitoring is not just an operational tool—it is a strategic shield against compliance risks and financial losses.

A Strategic Leap: Why Sunshine Developed TMS

Traditional methods—especially contact-based probes—had significant shortcomings:

• Risk of contamination from physical contact.

• Inaccurate readings due to material buildup on probes.

• Reactive control where deviations were discovered too late.

The contrast became visible with the adoption of non-contact infrared (IR) thermal sensors (M18TIP8Q from Banner Engineering USA). Installed through dedicated viewports, these sensors measure thermal radiation directly from the tablet bed, ensuring real product temperature readings without contamination risks.

This innovation, coupled with a robust software ecosystem, turned temperature monitoring into a proactive, real-time control system—aligned with global regulatory expectations.

Architecting the Solution: Hardware and Software in Harmony

Overcoming Environmental Challenges

One challenge was ensuring sensor accuracy in the harsh environment of coating rooms (steam, hot air, and dust). Sunshine designed specialized sensor isolation and shielding viewport, allowing sensors to read only the tablet bed temperature, unaffected by surrounding noise.

Key Features and Benefits

Technical Specifications: Built for Reliability

• Sensors: Infrared Thermocouple (Banner M18TIP8Q), range 0 °C to 300 °C

• Accuracy: ±1% of measurement or ±1 °C

• Controller: Ethernet Analog PLC

• Interface: 5.7” Touch HMI

• Output: Thermal Printer, USB, Ethernet

• Compliance: 21 CFR Part 11, GAMP 5

• Power Supply: 220V AC, single-phase

The Validation Framework: Assurance by Design

Compliance is not an afterthought—it is embedded in Sunshine’s TMS through a four-stage validation lifecycle:

1. Design Qualification (DQ) – Proof system meets URS and regulatory requirements.

2. Installation Qualification (IQ) – Confirms correct installation in client environment.

3. Operational Qualification (OQ) – Demonstrates functional reliability.

4. Performance Qualification (PQ) – Proves consistent performance in real production.

This process ensures faster approvals, smoother audits, and peace of mind for manufacturers. 

The Value Proposition: Tangible ROI

Sunshine’s TMS delivers returns far beyond compliance:

• Guaranteed Compliance – Simplifies audits, reduces risk of penalties.

• Superior Product Quality – Prevents coating deviations before they cause waste.

• Operational Efficiency – Automated logging reduces labor and error.

• Data Integrity & Traceability – Audit-ready records and secure backups.

• Future-Proof Scalability – Retrofit-friendly, modular, and expandable.

• Downtime Reduction – Troubleshooting guides built-in for quick fixes.

Partnership Beyond Technology

Sunshine Corporation positions itself not just as an equipment provider but as a long-term partner. Clients benefit from:

• Pre-defined documentation to accelerate commissioning.

• On-site and remote training programs.

• One year of dedicated post-installation support.

• Future upgrades ensuring ongoing compliance.

Conclusion: A Standard in Pharmaceutical Manufacturing

In today’s pharmaceutical landscape, compliance and quality are not negotiable—they are the very foundation of trust with patients, regulators, and markets. Sunshine’s Temperature Monitoring System embodies this principle by uniting sensor innovation, intelligent software, and a rigorous validation framework.

The result is a system that does more than monitor—it guards, documents, and assures the integrity of every coated product.

In short: Precision temperature monitoring is not just compliance—it’s competitive advantage.

Contact us should you have any queries and we will be glad to assist.