Tag Archives: cold chain management

WHO’s World Blood Donor Day 2016: Blood Connects Us All

The World Health Organization (WHO) has declared Tuesday, June 14, 2016 as World Blood Donor Day.  The theme is “Blood Connects Us All”.

shutterstock_419643730  wallpaper-girl

In May 2005, at the Fifty-Eighth Session of the World Health Assembly, 192 Member States of the WHO adopted resolution WHA58.13 to establish World Blood Donor Day as an annual event, to be celebrated each year on 14 June.

According to the WHO, “The safest blood donors are voluntary, non-remunerated blood donors from low-risk populations. In the key global fact and figures of 2011 (Fact sheet number 279), in 62 countries, national blood supplies are based on 100% or almost 100% (more than 99.9%) voluntary unpaid blood donations. Forty countries collect less than 25% of their blood supplies from voluntary unpaid blood donors. The primary goal of the WHO is for all countries to obtain all blood supplies from voluntary unpaid donors by 2020 in accordance with World Health Assembly resolution 28.72, which was adopted in 1975.”

Ms. Jennifer Marcum, Sentry BioPharma Services’ CEO, acknowledges the significance of the international event by scheduling an appointment to donate whole blood at the American Red Cross on June 17, 2016.  Ms. Marcum offers, “The National Institutes of Health (NIH) says approximately five million Americans require blood transfusions every year.  The need is continuous.  To this day blood cannot be manufactured on an industrial scale.  There is some research being done at The University of Edinburgh to create blood type O red blood cells using pluripotent stem cells, but a true biological blood substitute has not been commercially approved by the FDA.   So, in the absence of a safe and effective blood surrogate, we donate.  A blood donation not only forges a bond between human beings, but it also creates links to our local and global community.  It is the one common denominator among us all.”

Ms. Marcum continues, “Protecting the integrity of the entire blood cold chain should be an integral part of the global blood distribution system.”  The WHO says, “Deviations from specified temperature ranges and conditions during storage and transportation of blood and blood products can seriously affect the viability of the constituents of blood, thus leading to reduced clinical benefits. It can also increase the risk of bacterial proliferation in blood components during storage and may cause potentially life-threatening transfusion reactions, such as septic shock and even death.”

The WHO notes, “A break in the blood cold chain leads to wastage and discard of unsuitable blood units, which may adversely affect the supply of blood and blood products for transfusion. An effective blood cold chain is essential for the countries to implement strategies to expand safe blood transfusion services to cover wider geographic areas and achieve universal access to safe blood transfusion for all patients who need transfusion.”

Sentry BioPharma Services offers biological product storage to pharmaceutical companies, hospitals and organizations with need for validated refrigerated (+2°C to +8°C) storage and temperature-sensitive product shipping services.  For more information about how Sentry’s GMP warehouse can help protect the integrity of the blood cold chain and biological products in general, contact Sentry via email or by phone at 1-866-757-7400.

Five Benefits of a Self-Directed FTZ Audit

On Thursday, April 21, 2016, Sentry BioPharma Services completed a self-directed (voluntary) inspection of the company’s foreign trade zone (FTZ) and compliance with 15 CFR Part 400.  Randall L. Higgins, Sentry’s Senior Manager of Compliance and Validation, defines five main benefits of an independent compliance evaluation as follows:

Establishes a Professional Relationship

Sentry BioPharma Services establishes a professional relationship with an experienced and specialized service provider for several reasons.  Familiarization with Sentry’s organization, employees, facility layout, policies, procedures, daily activity and compliance history facilitates the uptake of tacit knowledge.   Clear communication channels streamline response time when trouble-shooting a problem or developing a new business opportunity.  Having an established relationship also creates a new avenue for gaining important information and insight, which is especially important as new regulations evolve.

Builds Regulatory Alignment

Tapping the knowledge and experience of a foreign trade zone expert helps a company build stringent alignment with requirements of various regulatory agencies (DEA, FDA & CBP).  Normally, the specialized consultant starts with an unbiased gap analysis to test the company’s system for robustness.  This analysis offers a realistic picture of the present state of affairs.  It also simulates the way a regulatory agency may conduct an impromptu CBP inspection.  The non-threatening environment fosters collaboration to proactively reveal unknown deficiencies and opportunities for improvement.

Drives a Competitive Advantage

Teaming up with a foreign trade zone specialist serves as a competitive advantage.  The FTZ consultant identifies operational inefficiencies and offers suggestions to improve routine and in some cases repetitive tasks.  The import/export professional advice can lead to the elimination of non-value added tasks, simplification of paperwork and the reduction of redundancies.  In some cases, the objective analysis minimizes or eliminates duties, processing fees, violations, fines and penalties.

Cooperates with Administrator of the Grant of Authority

Sentry BioPharma Services’ FTZ is part of Zone 72 and is identified as subzone 011.   Sentry’s zone is located at the Indianapolis International Airport (IND) and is not considered within the customs territory of the United States.  Sentry intends to continue participation in the Federal Foreign Trade Zone program for years to come.  By voluntarily completing an internal FTZ system audit, it demonstrates Sentry’s intent to maintain a good compliance record year-after-year with its grantee.

Cultivates New Business Opportunities

The advice of a foreign trade zone consultant typically brings solutions to pain points in the pharmaceutical supply chain.  In many cases, unique problems serve as opportunities to grow the business and expand the service offering. Clients with temperature-sensitive pharmaceutical products are often looking for ways to better control the pharmaceutical supply chain.  Protecting pharmaceutical product integrity tops the list.  Also high on the list of client needs are expediting shipping and/or customs clearance requests.   Customers benefit from the added level of drug product protection which results in time-saving and overarching risk mitigation.

Mr. Randy Higgins expands, “Sentry BioPharma Services has delivered a pristine regulatory compliance record to existing and prospective clients’ year-after-year.  By embracing self-directed and independent evaluations, Sentry protects the safety, identity, strength, purity and quality (SISPQ) of the pharmaceutical products and controlled substances moving through our GMP warehouse on a daily basis.”

Sentry’s active FTZ status and customs bond support import optimization and control of temperature-sensitive biological and pharmaceutical ingredients, materials, semi-finished and finished drug products.  For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import process, contact Sentry via email or by phone at 1-866-757-7400.

https://enforcement.trade.gov/ftzpage/grantee/regs.html

International Trade

 

 

 

Proper Blood Storage and Distribution Helps the Shortage

Did you know that blood cannot be manufactured?  In this age of advanced pharmaceutical and biological product development, that comes as quite a surprise to many; but it is true.  The American Red Cross faces blood shortages.

According to the American Red Cross website:

  • One pint of blood can save three lives.
  • Every two seconds someone in the U.S. needs blood.
  • A single car accident victim can require as many as 100 pints of blood.
  • Approximately 36,000 units of red blood cells are needed every day in the U.S.
  • Nearly 7,000 units of platelets and 10,000 units of plasma are needed daily in the U.S.
  • Nearly 21 million blood components are transfused each year in the U.S.
  • The average red blood cell (RBC) transfusion is approximately three pints.
  • More than 1.68 million people are expected to be diagnosed with cancer in 2016. Many of them will need blood, sometimes daily, during their chemotherapy treatment.

Ms. Jennifer Marcum, Sentry BioPharma Services’ CEO, acknowledges the need by stating, ” Blood can only come from generous donors.  There are approximately 7 million blood donors in the U.S.  A healthy donor may donate red blood cells every 56 days.  Most people don’t think they will need blood, but there is a tremendous continual need.”

Ms. Marcum continues, “Proper blood storage and temperature-sensitive product shipping is of great importance to the blood supply chain.  After donated whole blood passes processing and testing, red blood cells are stored in refrigerators at 6°C for up to 42 days.  Blood used in an emergency must be readily available on the shelves before the event occurs.  Effective cold chain management protects the biological product’s integrity.”

Sentry BioPharma Services offer biological product storage to pharmaceutical companies, hospitals and organizations with need for validated refrigerated (+2°C to +8°C) storage and temperature-sensitive product shipping services.  For more information about how Sentry’s GMP warehouse can help protect the integrity of the blood supply chain and biological products in general, contact Sentry via email or by phone at 1-866-757-7400.

RedCrossA