Chemical Temperature Indicators in Transport of Biologics

Pharma IQ
Posted: 04/11/2011

The transportation of temperature-sensitive products has always been a significant challenge for the pharmaceutical and biotech industries to overcome. With the globalisation of operations, the problems faced by manufacturers are considerable when attempting to maintain quality and reduce costs through careful cold chain management. According to one company, chemical temperature indicators – used mainly for vaccines in World Health Organization (WHO) initiatives – could have wider applications in several areas of business.

Chemical indicators have been used as vaccine vial monitors (VVMs) in global immunisation schemes for a number of years, but according to one provider, their properties could be put to wider use across the pharmaceutical industry. This could potentially ease some manufacturers' worries about cold chain product integrity, such as the concerns raised in a Harris Interactive Research survey conducted among US physicians last year.

Commissioned by Temptime, the study revealed that most distributors of medicines were concerned that "heat-damaged products resulting from cumulative exposure to temperatures outside the specified temperature range pose a health risk to patients". The fact of the matter is that cold chain breaks have existed in clinical practice since temperature sensitive compounds were very first developed. And with the rise of globalised operations, the challenge of reducing them has become ever more pressing.

Donald Allegra, fellow of the American College of Physicians (ACP), commented: "Now, with advancements in science and medicine trending toward increased use of biologics, vaccines, and other temperature-sensitive medicines, we need far more vigilance around the cold chain to protect life-saving medicines from temperature abuse, and protect our patients from associated risk stemming from undetected temperature abuse."

Ted Prusik, senior vice president of Temptime, suggested that indicators like those used as VVMs to support global immunisation initiatives, could prove effective in delivering an improved understanding of temperature exposure across the pharmaceutical industry. In 2009, Temptime supplied almost 500 million VVMs for Unicef vaccines. "The rationale for their use was developed years ago because of known issues in the field. The programme needed a low-cost solution that could help monitor products in countries with poor temperature control," Mr Prusik explained.

The Harris Research study found that cold chain breaks were, somewhat alarmingly, quite common. Most respondents claimed to have experienced such an incident in their clinical practice, but different issues were found to be affecting varied professions in unique ways. Specialists reported a greater number of delivery-related cold chain breaks, which occur when products are in transit. Meanwhile, paediatricians had experienced more storage-related issues, arising once the products had arrived at the facility.

In a separate study, conducted a few years earlier in 2006, the California Department of Public Health examined the storage and handling of vaccines in ten regions of the San Francisco Valley. It identified $2.3 million (£1.25 million) in wastage. "A lot of that probably could have been saved had VVMs been used to reveal true exposure," suggested Mr Prusik. He added that "robust and flexible" use of indicator technology could have applications much farther-reaching than just for products in the vaccine category. They could potentially minimise risks in the transport of other protein-based compounds, bloods and chemotherapeutic agents, Mr Prusik claimed.

He went so far as to imply that even non-cold chain products could provide uses for chemical indicators, to uncover details of other types of temperature exposure. This could prove particularly valuable where pharmaceuticals are being transported by mail order delivery. Mr Prusik added: "Often these are high-value products, so the indicators could give patients a feeling of security."

Marie Chernock, an independent consultant to Temptime, suggested: "Companies have advised patients not to use products because of temperature concerns. If these indicators were to be used, patients could be directed to call a manufacturer hotline in the event of a colour change in an indicator that might mean the product had been heat damaged. The hotline representatives could help direct patients as needed."

As manufacturers continually seek new ways to reduce the risks involved with transporting temperature and time-sensitive products, these kinds of suggestions could help manufacturers look at measures they can take to achieve their cold chain optimisation goals.

Pharma IQ
Posted: 04/11/2011

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