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The pharmaceutical industry accounts for about 60% of the global market, and it continues to grow by the day. Many of these products are time and temperature-sensitive. By monitoring temperature, you guarantee the safety and quality of your products. Managing temperature deviations entails being accurate with indicator readings and interpretation of color changes.


With the following article, we would like to give an insight of what you need to know about the different types of indicators in the market before making a purchase decision.


Chemical Indicators


Chemical indicators are chemical-based labels used for monitoring temperatures. They are simple and inexpensive.


Available Chemical Indicators on the Market

The global chemical indicator market was $54 million in 2020, and experts predict that it will reach $80 million by 2027. As such, there are many chemical indicators on the market customized to suit your needs. They help you monitor temperature deviation, reducing possible damage to your products during shipment and storage.


Chemical indicators fall into the following six classes depending on their use:

  • Class 1 chemical indicators are ideal for monitoring high-end items.
  • Class 2 chemical indicators are custom-made to test and understand air removal and steam penetration using the Bowie-Dicks test.
  • Class 3 chemical indicators are specific variables used to expose a single sterilization product procedure.
  • Class 4 chemical indicators comprise multiple variations and react to various sterilization processes.
  • Class 5 chemical indicators react with all the possible and essential variables.
  • Class 6 chemical indicators, also known as emulating indicators, usually verify the sterilization cycle while reacting with all critical variables.

How Can I Determine If the Chemical Indicator Is a Good Choice?

The choice of whether a chemical indicator is ideal solely depends on the requirements of your shipment; therefore, ask yourself the following questions:

  • Does it cover my temperature range?
  • Does it have the required certifications?
  • What do you know about the failure rate?
  • Is the lifetime sufficient?
  • Is it easy for the receiver to read/understand the results?
  • Do I require a stable budget for my shipments?
  • Would using a stable budget save time and money?
  • Can I share the results of the indicator easily?


11.1_Teaser_ITS_WHO_PQSKit Level Temperature Monitoring Options

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Electronic Indicators


Electronic indicators are battery-operated, and you can use them to track both time and temperature throughout your product's shipping. Apart from their many benefits, these devices also have drawbacks.


Let's look at the pros that make people prefer electronic indicators:

  • They have LED or LCD screens that are easy to read and notify you of alarms.

  • They monitor products at any point in the supply chain, which is crucial for high-priced goods in transit.

  • They allow you to monitor the temperature variations and time taken during shipment or storage.

  • Due to high performance, they reduce any reshipping costs from damaged products due to deviations.

  • They're easily customized to your specifications, hence ensuring customer satisfaction by eliminating deviations.

Is the Monitoring System GAMP 5 Validated?

As a pharmaceutical company, you must operate by a given set of codes that validates your computer systems. Your systems should prove your planned process is per the initial intended purpose. ELPRO uses the Good Automated Manufacturing Practices (GAMP 5) model to ensure validation.


High standards in pharmaceutical industries are needed to provide quality drugs and medicine to consumers. GAMP 5 validated monitoring systems help pharmaceutical companies achieve that. There is no need to perform GAMP 5 validation in-house if the supplier already provides the documentation. The documents are suitable for official audits.



11.2_Teaser_GAMP5_VModelGAMP 5

Get a breakdown of the V model.




Time and Temperature Indicators (TTI)

Time-temperature indicators are small, thin, and durable devices for monitoring temperature. The historical data in such an indicator continuously records temperature variance to ensure compliance while conserving the environment by recycling consumables.


Some of the benefits your company can get from using TTIs include:

  • Cost-efficiency since you spend less when using the devices during shipments.

  • Optimization for a wide variety of products with different shelf lives.

  • Standard or customized configurations.

  • Optimization for use in lines with high-speed production.

  • Easy to store, safeguard, and use.

The pharmaceutical industry observes strict quality standards, product safety, and sustainability. With these needs constantly growing, demand for intelligent solutions catalyzes the time-temperature indicators market. Experts forecast a compound annual growth (CAGR) of 6.6% from 2020 to 2030, meaning consumers will continue getting high-quality products. For example, the LIBERO ITS is the world's first wireless electronic time and temperature device that manages the temperature deviation of your products to a maximum of six alarm levels.


Stability Budget Indicators


Stability budget indicators help you access more data and experience less product loss in various ways. Even if you have a temperature excursion, the alarm settings will consider the stability budget for the product in transit. As long as the stability budget is still applicable, the alarm status will not go off, meaning the products will still be suitable for use.


With chemical or simple electronic indicators, the alarm state would immediately go off, and two steps follow:


  1. The product goes into quarantine until a quality manager looks at the data in detail.
  2. The product becomes unavailable in the market, and the patient has to wait, leading to a loss of time and money.


Download_Icon_WP_Vaccine_EN_20200924Chemical vs. Electronic Indicators

FREE download on how to choose between the two.





Documentation Criteria


The critical factor here is how to document the records after monitoring temperature. There are three main criteria used:

  • Documentation should be secure. Only authorized users should have access to the documentation to ensure integrity of data.

  • Documentation should be easy to access. Documentation should be readily available to authorized users or auditors.

  • Is it easy to document if a product is safe for use after shipping? When time is of the essence, the status of the shipment should be easy to acquire and distribute.


11.2_Teaser_DemoITSLIBERO ITS

Test the electronic indicator best for you.





Rely on a Specialist


When it comes to transporting and storing pharmaceutical products, monitoring temperature properly is essential. Some monitoring tools may be expensive as initial investments, but an efficient system saves a lot more money in the long run by preventing product loss. It also ensures you remain compliant with regulations. Whether you're in the market for an electronic or chemical indicator, consider the needs of your products and consumers to select the right solution. Learn more about managing temperature-controlled logistics at ELPRO.

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