The vaccine options for COVID-19 are arriving, with numerous pharmaceutical manufacturers submitting their applications, and governing bodies the world-over reviewing and authorizing their use. Distribution speed and efficiency is vital, but it’s important to recognize the exceptionally hard work vaccine manufacturers face with this time-sensitive and monumental task while following stringent guidelines and protocols to make it happen.
Some are questioning the speed-to-market and whether a vaccine developed and approved in such a short timeframe would be safe for use. While the time it has taken to bring vaccine options to approval is shorter than vaccines in the past, critical steps associated with the development and approval process have not deviated from traditionally longer development cycles, and the protocols associated with them. These include cleaning regulations, Standard Operating Procedures (SOPs) and required industry Good Manufacturing Practices (GMP).
The rigorous steps a vaccine goes through to be approved for distribution are vast and were addressed in detail in Part 1 (Vaccines: An Overview of this Life Saving Innovation) of this series. Once a vaccine garners approval, manufacturing facilities begin mass production. This article focuses on the critical cleaning and disinfection steps, and the associated regulations manufacturers take in their facilities in order to ensure product safety and the highest standards of product quality.
Regulations and SOPs
There are numerous governmental regulations and industry standards pharmaceutical manufacturers must follow when establishing cleaning and disinfection SOPs. This ensures the highest quality and safety of the product with every ‘batch’ of pharmaceuticals produced, including the COVID-19 vaccines.
Chapter 1072 of the United States Pharmacopeia (USP <1072>) document states numerous recommendations for cleaning and disinfection in controlled environments. Microbial contamination is critical to the quality and safety of any drug produced and specific steps are taken to prevent product contamination. As such, USP <1072> details the different types of disinfectants (high-level, intermediate-level, and low-level) and action necessary to remove any contamination that would affect the drugs produced. Within this document, specifically page 620, all considerations are listed when selecting a disinfectant for use in a pharmaceutical manufacturing environment, including, but not limited to:
- The number and types of microorganisms to be controlled
- The concentration, application method and contact time
- Possible need to maintain a residual bactericidal activity of the disinfectant on the surface
- Disinfectant rotation
- Steps that need to be taken to avoid the contamination of the pharmaceutical products by a disinfectant
Facilities follow USP<1072> for everything from disinfection selection and proper usage to disinfectant rotation.1 These guidelines are then used to build Good Manufacturing Practices (GMP) in pharmaceutical facilities. This document is 63 pages long in detailing various aspects of GMPs that must be followed to ensure a safe product. These guidelines are used to create Standard Operating Procedures found in the most critical environments in the world.
Items covered by SOPs include, but are not limited to:
- Proper gowning techniques
- Movements and behavior of personnel to prevent contamination
- Environmental monitoring and methods used
- Endotoxin control
- Container, workspace and area preparation
- Disinfection efficacy
- Sterility Testing
- Training protocols2
In Europe, the Eudralex Annex 1 draft that is currently under revision offers cleaning and disinfection guidelines and has updated some terminology to more clearly define the importance of disinfection. Other changes include, but are not limited to:
- Recognizing cleaning and disinfection as two distinctly separate practices
- Referencing the importance of residue removal
- Including a sporicidal agent in the process
- Importance of environmental monitoring to assess the effectiveness of a disinfection program
Although some people might think that COVID-19 vaccines are being developed too quickly, it’s important to note that researchers and pharmaceutical companies have been exclusively committed to creating this vaccine for months. The regulations they must follow have not changed. They know what’s at stake for the entire population.
mRNA vaccines, like the COVID-19 vaccine, are new and exciting but they are not unknown. Researchers have been studying and working with mRNA vaccines for decades. Because of how the mRNA vaccines are manufactured, the process can be standardized and scaled up making vaccine development faster than traditional methods. Future mRNA vaccine technology may allow one vaccine to provide protection for multiple diseases which would decrease the number of shots needed for protection against common vaccine-preventable diseases.3
What is Contec seeing?
Contec has worked with pharmaceutical manufacturers for years developing strategic plans for contamination control in their critical environments. This year, that partnership has been stronger than ever as the need is greater for cleaning and disinfection products.
In the first quarter of 2020, COVID-19 pressed the need for cleaning consumables to the brink. Contec, along with other manufacturers, responded to the call, increasing our manufacturing and training capabilities, working alongside customers at both the supply-chain and end-user levels to find product alternatives, and remaining in constant communication to fill orders as quickly as possible.
The increased need for vaccine production capacity has resulted in an increased volume of consumables (wipes, mops), disinfectants and hardware (buckets, mop frames and handles). Cleaning and disinfecting activity has significantly ramped-up and will continue to do so with the increased vaccine production in the coming months. Contec has been working with our manufacturing facilities around the world to ensure we can meet the needs of our customers to the absolute best of our ability. We are proud to be part of the process, and proud of the work our customers are doing, and will continue to push through with products necessary to meet the stringent regulations they must follow to create billions of contamination-free doses of vaccines for the global population.
Traditional vaccine timelines can shift based on global need and urgency. The COVID-19 pandemic has proven that people can come together to produce a vaccine for the masses in a relatively short time. This shortened timeframe does not mean regulations are not followed. In fact, this means facilities are having to follow these regulations more closely than ever. They understand the urgency and they are rising to the challenge.
mRNA vaccines are held to the same rigorous safety and effectiveness standards as all other types of vaccines. The only COVID-19 vaccines the Food and Drug Administration (FDA) will make available for use in the United States are those that meet these standards.3
Contec is proud to play a part in keeping these facilities in compliance with stringent and specific regulatory requirements.
Note: This article is part one of a three-part series. Be sure to take your research further by checking out: