punctured pharmaceutical co med

























Introduction

The Pharmaceutical field is the origin of the technologies adopted today in the Aseptic filling, closing and inspection of beverages without any added preservatives.  Are the Food and Beverage Packaging standards competing with the Pharma standards of, as an example 10 years ago ?    Unfortunately, no.   To feel how delayed is in terms of safety all the Food and Beverage Packaging with respect to Pharma, we’ll quote in the following part of an U.S. Food and Drug Administration Recall Press Release.   Here, Hospice, Inc. the worldwide leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, announced a voluntary nationwide (US) recall of certain lots of several lifecare products due to potential for Leakage.  1000 ml (1 liter) leaking containers recalled because potentially punctured, due to a defect in a Conveyance system:

“The issue, which Hospira notified customers (…), was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container. 

The puncture in the primary container may result in leakage that is difficult to detect. 

Leakage may result in an open system, which has the potential for: 

  • contamination, 
  • compromised sterility, 
  • drug waste, 
  • spillage, 
  • inadequate or inconsistent solution/medication dosing, 
  • delay in therapy, 

all of which may require medical intervention and should be reported to Hospira and/or the U.S. Food and Drug Administration (FDA).   Hazardous topical exposure may occur if a hazardous drug is added to the flexible container.   Hospira’s product insert packaged with LifeCare flexible intravenous containers recommends providers do not administer unless solution is clear and the container is undamaged. 


pharma packaging line med hr

Root Cause Analysis

The root cause is attributed to a defect in a Conveyance system, and corrective actions have since been implemented to prevent a reoccurrence.   To date there have been no reports of adverse events associated with this issue for the impacted lots.  The manufacturing issue that caused this incident has been addressed. Hospira recommends impacted customers check with their local Hospira representative or with Hospira Customer Care regarding replacement product. 

  Pharmaceutical Packaging Lines, however running much slower than the majority of Food and Beverage Lines, are much more critical.  In the Case Study presented here, originating by the U.S. Food and Drug Administration, the liquid into the containers is meant for intravenous injection



















What is affected

The affected lots (see table below) were originally distributed by Hospira to direct accounts from September 2013 through October 2014:

  • Normosol®-R pH 7.4 Multiple Electrolytes Injection Type 1, USP; 1000 mL container
  • Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP; 1000 mL container
  • 5% Dextrose Injection, USP; 1000 mL container
  • 5% Dextrose and 0.45% Sodium Chloride Injection, USP; 1000 mL container
  • Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container
  • 5% Dextrose and 0.9% Sodium Chloride Injection, USP; 1000 mL container
  • Lactated Ringer's Injection, USP; 1000 mL container
  • Normosol®-R Multiple Electrolytes  Injection Type 1, USP; 1000 mL container
  • 0.9% Sodium Chloride Injection, USP; 1000 mL container
  • 0.45% Sodium Chloride Injection, USP; 1000 mL container
  • Sterile Water for Injection, USP; 1000 mL container


Solution

Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately.   This recall is being carried out to the medical facility/retail level (both human and veterinary).   Please notify all users in your facility.   If you have further distributed the recalled product please notify any accounts or additional locations which may have received the recalled product from you and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level.   In addition, customers should inform potential users of these products in their organizations of this notification.   Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned”

pharma process med



Links to other Case Studies:





                                                                                                                                                                                                                                                                                                                                                                                                                                                         
Webutation
                                                                                                                       © 2013-2015 Graphene.  All rights reserved                                                         DMCA.com Protection Status                    

                                     
                                              
TRUSTe Privacy Policy Privacy Policy
Site protected by 6Scan