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Pharmaceutical factory with thermal validation service

In the ever-evolving world of pharmaceuticals, compliance with regulations is essential. Our thermal validation service helps you meet these standards while protecting your product and your reputation. 

What is Thermal Validation in the Pharma Industry?

It refers to the process of verifying the performance of equipment used to control temperature-sensitive processes. This includes processes such as storage, transportation, and production of pharmaceutical products. The aim of thermal validation is to ensure that these processes are consistent and that the temperature is kept within specified limits to ensure product quality and efficacy. 

The thermal validation process involves data loggers, temperature probes, and other monitoring devices to measure and record the temperature of the equipment and the product being stored or transported. 

Our top thermal validation services include:

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Equipment qualification

Verifying that the equipment used in temperature-sensitive processes is suitable for the intended use and can keep the desired temperature within specified limits.

Monitoring and data collection

Using data loggers, temperature probes, and other monitoring devices to measure and record the temperature of equipment and products during storage, transportation, and production.

Data analysis

Evaluating the data collected from monitoring and data collection to verify that the temperature control system is functioning within the desired range and can support a consistent temperature over time.

Documentation and reporting

Documenting the results of thermal validation assessments, including any deviations or issues found, and preparing reports that summarize the findings.

Re-validation

Regularly re-evaluating the equipment and processes used in thermal validation to ensure ongoing compliance with regulations and to keep product quality.

In India, the compliances to be followed for thermal validation services in the pharmaceutical industry are regulated by the Central Drugs Standard Control Organization (CDSCO). The following are some of the key compliances to be followed: 

– Good Manufacturing Practices (GMP) 

– Good Documentation Practices (GDP)

– World Health Organization (WHO) guidelines 

– International Organization for Standardization (ISO) 

– International Conference on Harmonization (ICH) guidelines 

– Food and Drug Administration (FDA) 21 CFR Part 11 Compliance 

– International Organization for Standardization (ISO 9001 & ISO 45001) 

– Occupational Safety & Health Administration (OSHA) 

– EN285 (European Standards) 

– Parenteral Drug Association (PDA) 

– International Society for Pharmaceutical Engineering (ISPE) 

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Thermal validation services are essential for a variety of industries that handle temperature-sensitive products or processes 

  • Pharmaceutical industry: Pharmaceutical companies require thermal validation services to ensure the quality, safety, and efficacy of temperature-sensitive products, such as vaccines, biologics, and medications. 
  • Biotech industry: Biotechnology companies require thermal validation services to ensure the preservation and stability of temperature-sensitive products, such as cell lines, biologics, and vaccines. 
  • Food and beverage industry: Food and beverage companies require thermal validation services to ensure the safety, quality, and freshness of temperature-sensitive products, such as dairy products, meat, and produce. 
  • Chemical industry: Chemical companies require thermal validation services to ensure the safety and quality of temperature-sensitive products, such as hazardous materials, flammables, and refrigerants. 
  • Medical device industry: Medical device companies require thermal validation services to ensure the safety and effectiveness of temperature-sensitive products, such as implantable devices, surgical instruments, and diagnostic equipment. 
  • Life sciences industry: Life sciences companies require thermal validation services to ensure the stability and efficacy of temperature-sensitive products, such as lab reagents, samples, and specimens. 
  • Logistics and supply chain industry: Logistics and supply chain companies require thermal validation services to ensure the temperature control and preservation of temperature-sensitive products during storage and transportation. 

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FAQ's

1.What is thermal validation?
Thermal validation is a process of testing and validating the heating, cooling, and temperature control systems of equipment and facilities used in pharmaceutical manufacturing, storage, and distribution. It is important to ensure the stability, efficacy, and safety of pharmaceutical products.

 

2.Why is thermal validation important?
Temperature control is critical to ensuring the stability, efficacy, and safety of pharmaceutical products. Even slight variations in temperature can affect the potency, stability, and shelf life of pharmaceutical products. Thermal validation helps to ensure that temperature control systems are operating correctly and are capable of maintaining the required temperature ranges for pharmaceutical products.

 

3.What are the benefits of thermal validation?
The benefits of thermal validation include:

Increased product quality and safety
Compliance with regulatory requirements
Reduced risk of recalls and product liability lawsuits
Improved efficiency and productivity
Reduced operating costs

 

4.What are the different types of thermal validation?
There are two main types of thermal validation:

Equipment validation: This involves validating the temperature control systems of individual pieces of equipment.
Process validation: This involves validating the entire manufacturing process, including the temperature control systems.

 

5.What are the steps involved in thermal validation?
The steps involved in thermal validation vary depending on the specific equipment or process being validated. However, the general steps include:
Planning and development
Installation and qualification
Operational qualification
Performance qualification
Documentation

 

8.What are the regulatory requirements for thermal validation?
The regulatory requirements for thermal validation vary depending on the country and the specific product being manufactured. However, the most common regulatory requirements include:

Good Manufacturing Practices (GMP)
International Conference on Harmonization (ICH) guidelines
Food and Drug Administration (FDA) regulations

 

Ensure Your Product's Safety with Incepbio's Expert Thermal Validation Services!