The History of Alliance

Compliance Issues in the Pharmaceutical Industry

Wednesday, January 20, 2021
The Pharmaceutical Industry is one of the most highly regulated industries, with many rules and regulations enforced by the government to protect the health and well-being of the public. Those in the industry face the incredibly challenging task of complying with many rules and regulations across all aspects of their business. In fact, compliance pressures in pharma have never been higher.  
 
The US FDA releases an annual data summary of inspection observations by industry. In 2019, there were a total of 81 warning letters issued to finished product manufacturers worldwide, the most since the fiscal year 2015. Surprisingly, the majority of those warning letters were issued to US companies.  
 
Along with warning letters, the FDA also issues Form 483s (these are issued to firms at the conclusion of an inspection when an investigator has observed any condition that may constitute violations). In 2019, there were a total of 779 Form 483s issued to the Pharmaceutical Industry (categorized as “Drugs”) compared to 716 in 2018. While several different violations saw an increase in frequency, one of the top six relates to equipment cleaning and maintenance. 
 
These compliance issues fall under 21 CFR 211.67(a). This FDA CFR dictates that “equipment and utensils are sanitized, maintained, and cleaned appropriately to prevent malfunctions or contamination.” 
 
The stringent sanitization procedures that equipment and utensils must undergo can create a significant amount of wear and tear. To ensure that equipment stays within compliance, it should be constructed of materials that can endure such harsh environments.  
 
Historically, materials such as stainless steel and glass have been relied upon heavily for their outstanding and unique mechanical properties and inertness. However, there is another material with similar capabilities, with the additional benefits of lower costs and overall simplicity for specific applications: Silicone Elastomers.  
 
Silicone Elastomers 
 
Because of its stability, silicone is easy to sterilize. From Autoclave to Gamma irradiation, Ethylene oxide, and sterilization by e-beam, repeated sterilizations have shown no significant effect on the mechanical properties of silicone elastomers.  
 
Emerging regulatory requirements are showing favor to assemblies made from “well-known materials.” It is important to note that silicone tubes, gaskets and elastomers have been widely used in pharmaceutical manufacturing operations (or as packaging materials) successfully for more than 40 years. 
 
That being said, one must consider its benefits as well as its limitations. The challenge then becomes determining the appropriate compounds to achieve the desired results. That’s why it’s important to partner with a silicone manufacturer with the knowledge and experience to guide you through the process. 
 
Premium Synthetic Rubber 
 
Another material that is heavily relied upon in the Pharmaceutical Industry is non-latex rubber. This material is important because 3.5% of the world population is affected by latex allergy reactions.  
 
To protect from latex allergy reactions, many hospitals and schools have adopted policies to only use non-latex products. Products made from premium synthetic rubber offer high quality and consistency. They provide exceptional hold for medical facilities and can be sterilized using autoclaves and irradiation.  
 
Non-latex rubber bands are ideal for industrial and laboratory applications, home, school, workplace, medical facilities, medical supply wholesalers, medical parts, packaging and manufacturing facilities as well.  
 
Common Applications for Silicone and Premium Synthetic Products in the Pharmaceutical Industry: 
  • Securing surgical trays for sterilization
  • Tourniquets for venipuncture and blood draws
  • Pharmaceutical & medication packaging
  • To assist/secure items during surgical procedures 
  • Personal Protective Equipment (PPE) 
  • Bundling blood bags and medical tests 
  • Miscellaneous use within laboratory settings 
  • Elastic in surgical garments 

Alliance Rubber Company is built on over 97 years of rubber compounding and extrusion and has consistently delivered quality and innovative products to their customers. If you’re interested in learning more about our custom silicone or premium synthetic rubber products for the Pharmaceutical Industry, fill out our contact form and someone will be in contact with you! 

comments powered by Disqus