In the pharmaceutical industry, specimens and costly drug products are typically sensitive to temperature changes during shipment and storage. Box level temperature monitoring is helpful when individual shipments must be approved before use. Environmental measurements through various box level indicators are available to meet the unique needs of your application. In this guide, we explain all you need to know about successful temperature monitoring for your company’s most valuable deliveries.

 

3 Reasons People Want Electronic Box Level Indicators

 

1. Return on Investment (ROI)

Electronic indicators like the LIBERO ITS can do what freeze indicators, USB data loggers, and chemical indicators do with one tiny device. Stability budget information prevents quality products from being discarded, it expedites biologic drug development, approval, and commercialization to achieve a timely investment return.

 

2. Efficiency

Electronic box level indicators can be pre-configured with a specific product stability budget and temperature parameters. The indicators can be automatically attached to packages or bottles to expedite sending site packaging processes. The indicator’s information can be sent digitally to relevant parties, giving more information in less time than other indicators.

 

3. Easy to Use

The configurations quickly help you monitor the time and temperature information for the whole storage length or shipment. With high-priced items, you can watch the transit information throughout the journey. You can easily access the statistics on your smartphone and/or in the cloud to make informed decisions at specific points in the supply chain. Whether it be the configuration, the startup, or gathering the decision and data, the LIBERO ITS is easy to use.

 

 

 

Stability Budget – When Is It Required?

 

When transporting sensitive products designed for specific temperatures, there is a high chance they may reach your intended destination damaged. With airflow disruptions, extreme weather, and employee mistakes, establishing a stability budget that will allocate the time out of the storage point can prevent companies from prematurely discarding products after unfavorable temperature exposures. A stability budget is most beneficial for pricey or high-value packages.

 

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What is a Stability Budget?

 

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The following are applications where working with stability budget is a must:

 

 

 

Clinical Trials

 

The EU authorizes about 4,000 clinical trials every year, and the pharmaceutical industry sponsors more than 61% of these trials. Medical research and experiments observe biomedical or behavioral responses in medical interventions during clinical trials.

 

Here are some reasons why the stability budget in clinical trials is crucial and beneficial:

  • It facilitates a timely ROI by accelerating biological drug developments, commercialization, and approval.
  • It ensures your supply chain is flexible and viable for the drug you use in the clinical trials.
  • It indicates your product's quality, aesthetics, efficiency, and safety.

 

Pharma Supply Chain

 

A stability budget is helpful in several cases in the pharma supply chain, such as:

 

End-to-End Visibility

Although only 14% of pharmaceutical companies focus on end-to-end visibility, it is essential in the supply chain to prevent drug shortages, ensure drug safety, and boost resilience. For example, Covid-19 served to show the gaps in distribution and tracking, revealing the ability of the industry to adjust to demand patterns and disruption.

 

Direct-to-Patient (DtP)

The pharma arena is revolutionizing the medical industry with the DtP model. The technique stands on an integrated supply chain that ends in the hands of participants. DtP has come into focus due to the manual methods not tackling the complexity of multinational drugs schemes, like flexibility, minimal waste emissions, and cost and quality control.

 

Individualized Drugs

The growing demand for orphan drugs, biotechnology Covid-19 drugs, and personalized medicine is driving innovative biotech companies. Government initiatives oversee drug regulatory pathways, speed drug procedure approvals, reimbursement strategies, and standardize clinical studies. By breeding innovation and gene sequencing, the pharmaceutical sector focuses on improving the existing technologies.

 

 

What is the benefit of using a stability budget?

 

Use the correct product stability budget during box level temperature monitoring to access several benefits.

  • Prevent waste: A stability budget can eliminate the waste that occurs with other indicators when a drug is still fit for use after temperature excursions.
  • Maximize product life: A stability budget that captures time out of storage (TOS) with temperatures during storage, packaging and distribution can identify the appropriate temperatures your consumers must maintain to ensure product quality.

 

What Is Gene Therapy?

 

New trends in the clinical supply chain are adjusting to match the different markets in different countries, temperature variations, packaging duration, designing and transportation, and distribution centers. One such trend is gene therapy.

 

 

6171a7c2d0c68_4_6_1 Direct to Patent Impact to LogisticsNew trends are changing the clinical supply chain.

 

Identify challenges and solutions for temperature monitoring in the changing supply chain.

 

 

 

 

 

Gene therapy, also known as gene transfer therapy, is a treatment that introduces a normal gene into a person's genome to repair a mutation that causes hereditary diseases. When the nucleus of your mutant cell presents itself to a normal gene, the gene integrates into a chromosomal site that is different from your defective allele. Though this combination might repair the mutation, a newer transformation might occur when the gene pairs with other functional genes.

 

Examples include human gene therapy on somatic body cells and germline gene therapy, where you place corrected cells inside the germline. However, germline has been achieved in animals and not humans. The most crucial factor for these therapies is the equipment needed and the technology used for temperature monitoring. This guarantees the quality of the cells, sperms, eggs, or embryos for therapy effectiveness. Cancer prevalence nowadays is providing new ventures for investing in targeted therapy developments.

 

Expensive Gene Therapies

Researchers are focusing more and more on rare genetic disorders and orphan diseases. These are top dollar projects leading to the most expensive drugs ever. Simply stated, it is imperative that these ingredients are preserved until their end use. A single treatment can cost up to $2.1 million. It is needless to say these treatments should be meticulously monitored.

 

 

World Health Organization (WHO) Vaccine Requirements

 

Before distributing vaccines to other regions, you must meet critical conditions like temperature limits, distribution practices, and drug administration.

 

The WHO protocol insists on using a stability budget on vaccine shipments for the following reasons:

  • An excellent stability budget maximizes a drug’s shelf life.

  • WHO’s controlled temperature chain uses the stability budget to help distribute vaccines during the last mile. Vaccines are able to reach more people and save more lives because of the flexibility of temperature excursions determined by the stability budget.

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WHO PQS Time Temperature Indicators for Vaccines

 

WHO Type 1 and 2 Vaccines: Learn the Stability Budgets Allowed for Each WHO PQS Type

 

 

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Storing Pharmaceuticals

 

Apart from the shipment, it is also vital to consider the storage within the supply chain. To ensure complete box level temperature monitoring throughout the whole supply chain, you must also monitor the product sitting on the tarmac, in warehouses, in cold rooms, in pharmacies, and in hospitals, taking into account the stability budget of the product.

 

 

Are Your Indicators Worth It?

 

The right indicator can make or break your operation. The choice of either using an electronic or a chemical one is entirely up to you. Which indicator is right for you?

 

Examples of Chemical Indicator Failures

Chemical indicators are limited to a single temperature excursion, unlike electronic indicators that track the time and temperature over the entire shipment and storage duration. Since there is no stability data, chemical indicators provide no digital data for documentation and record-keeping.

 

Data Loggers for Box Level Use

Most companies will have a variety of box level indicators and loggers to meet the requirements of the individual products they ship. A real-time PDF data logger that is low-cost and small enough to attach to a small bottle or box easily is nonexistent. At this point in technology, the battery size required to gather stability budget data, handler data, geographic location data, and incremental environmental readings (temperature and humidity) for end-to-end monitoring (for two or more years) is not as compact as we would like. But, there are several options to monitor your unique product.

 

PDF loggers, real-time loggers, and box level indicators all have their unique benefits. A logger attached to several individual kits may be impractical, but an electronic indicator is small and economical—a pragmatic choice. Indicators are not always ideal for box level temperature monitoring. You may consider PDF loggers, Bluetooth® loggers, or real-time loggers to customize and collect even more data.

 

 

Why ITS?

 

If you are considering using the LIBERO ITS for your company, then you would be making an excellent decision because the option is:

 

  1. A perfect mix of standard box level indicators and data loggers.
  2. Fully covered throughout the supply chain.
  3. The first Indicator that considers stability budget
  4. Cheaper and can replace chemical, electric multi-level, and freeze indicators.
  5. Fully acknowledged by the WHO

 

What is WHO's Performance, Quality, and Safety (PQS)? 

 

WHO's PQS prequalifies devices and equipment for quicker and timely distribution of vaccines for NGOs or member states used in immunization programs. ITS is no exception and has been offered the PQS status E006 for the temperature monitoring devices.

 

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Vaccines and NGOs-Need a prequalified monitoring device?

 

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Conclusion

 

Choose the right box level indicator for your sensitive products. If you are looking for an intelligent indicator that can share data digitally, ELPRO can help simplify the entire supply chain to prevent product waste and ensure product safety for the market, hence boosting profitability.