Commentary -Impact of temperature control for pharmaceutical & Biomedical Products

By Manuchehr Mehdizadeh, Design/Build Engineers, Houston, Tx (USA).

Mission Critical : Solving temperature control for pharmaceutical applications requires techniques perhaps more complex than those used for data centers and food storage facilities.

Given the case of pharmaceutical , where India is the world’s third largest pharmaceutical producers , the impact is critical as even a slight drift of  0.5C temperature change can effect quality of transported drug. 

It is estimated that almost 20% of temp sensitive health- care products arrive damaged or degraded which is due to broken cold chain, including 25% of vaccines. 

Whether for data servers or pharma warehouses , maintaining a controlled temp is equally critical, but these environments must be maintained in vastly different manner .  In other words mission-critical temperature control is not one size fits all. 

Unlike modern data servers which could shut down if it gets too hot, pharmaceutical compounds have no such built-in safeties.  They could simply lose their ability to be effective , causing patients cholesterol levels  climb , blood pressure  spike , and infections  spread  thus impacting the quality of life for all.

Quality Safety : Medicinal products require controlled storage and transit conditions in order to ensure that their quality is not compromised.

This applies to low-risk products as well as high-risk products such as vaccines, insulin and blood products , which normally require storage temp between 2°C and 8°C.

Distributors of drug products are required to record storage and transportation temperatures, as well as being licensed by appropriate authorities. Temperature monitoring devices should be used to demonstrate compliance with the records that are kept.  This trend calls for a new paradigm to achieve regulatory compliance.  

At every point in the pharmaceutical distribution chain , precautions are required to minimize the effect of external conditions on quality and stability of product. 

It is mandatory that records should provide reliable up-to-date evidence of compliance, in case of audits and investigations from MHRA (Medicines & Healthcare Regulatory Agency ) and other stakeholders.    

It is advisable that distribution centers carry out an in-house compliance audit before deciding on a storage facility , transport system or taking on a new range of products. 

Chain of Custody :  During the storage and transit of pharmaceutical product,  the chain of custody and environmental constraints needs to be strictly documented. 

This includes R&D to manufacturing (production facility) , logistics & distribution , warehousing and clean room spaces (distribution centers) with its validation and finally the consumer (patients) that represent the ‘last mile’ in the logistics chain for pharmaceutical products . 

However what happens between that ‘extra mile’ and the ‘final mile’ the temp sensitive products may sit on a shelf for an extended period thus causing  this warehouse to become critical. 

As such industry inspectors must conduct regular audits of environmental  monitoring systems combining temperature, humidity, with automated alarm functions, real-time sensors where information is stored in cloud based servers for conducting analytics and identify problems.  

Market ; Of all the statistics emerging around the global pharmaceutical industry this year, two big numbers attract the attention of both manufacturers and their logistics partners: An over $260 billion, the amount the “BRIC” nations (Brazil, Russia, India and China) are poised to account for in pharmaceutical sales for by 2019. 

These numbers are noteworthy because they demonstrate that R&D follows logistics. As products evolve to meet demands for more targeted therapies, demand for more targeted logistics solutions grows as well. And that means a need for customization for everything from clinical trial material (ctm) samples to finished products.

Transport :  While in transit thru refrigerated truck carriers , GPS monitoring must track location and temperature ranges. In addition RFID (Radio Frequency Identification) based systems also used for tracking and reporting. 

Even airports have started to provide suitable cold storage facilities for pharmaceuticals.  In addition 24-hour fool-proof security and security monitoring systems need to be provided to ensure safety of pharmaceutical products.   

Packaging: However manufacturers still cannot rely on the supply chain alone. As such, the ability to pack for varying temperature ranges is evolving to meet diverse product needs.

Almost all packaging manufacturers are developing vacuum insulated panels (VIP) and phase change material (PCM) solutions that allow for easier handling and storage of temperature-controlled products and samples.

The new host of offerings and solutions means a multitude of choices when it comes to choosing the right packaging for a particular product. 

Compliance & Audits :  The impact of Good Distribution Practice (GDP) on temperature-controlled transport continues to grow.

In short, GDP including GMP emphasizes temperature control during the whole supply chain—no transport without temperature monitoring.

As it relates to pharmaceuticals specifically, GDP addresses Quality Management Systems (QMS) and documentation, personnel and training, risk management (including Standard Operating Procedures – SOPs), facilities/storage, transport and much more.

Due to increasing regulatory burden, quality departments within manufacturers’ supply chain operations are gaining more and more authority.

This, coupled with the complexity of regulatory compliance, means that various stakeholders on the manufacturing end must ensure that suppliers and transport partners comply with applicable regulations, taking a risk-based approach and enforcing audits and quality agreement. 

Submitted by: mmz@roxara.com : Design/Build Engineers, Houston, Tx (USA).

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