“Aseptic Filling, Weird Stuff”

Image

Or at least the CNBC Anchors think so …

Afton Scientific Sterile Clean Room

Sterile Aseptic Drug Manufacturing in our APA Clean Room at Afton Scientific

“The Fill Finish process of manufacturing has to be done under aseptic conditions to ensure there is no contamination. That capacity is at a premium. Weird right?” from CNBC on 01 February 2021

Why should it matter to you?

Admittedly, it is not common knowledge but certainly not weird stuff. If you have ever had medication injected via a syringe (think COVID-19 vaccine) chances are it was the product of aseptic fill. I don’t know about you but I’m not interested in a side serving of bacteria injected along with my vaccine. Neither should you be.

What is Aseptic Processing?

A critical feature of injectable drugs is that they are completely free of disease-causing microorganisms, such as bacteria. Unlike other forms of medication (such as pills, capsules, ointments, etc.), injections bypass most of the body’s natural barriers, and therefore sterility, or the complete absence of microorganisms, is crucial.

Generally, there are two methods of producing sterile product. The first is to assemble all the ingredients into the finished dose container (for example, vials or pre-filled syringes), and then sterilize the product, usually using high temperatures or radiation. This method has traditionally been the most common method used. However, many newer products such as biologically-derived materials such as mRNA and proteins, cannot withstand these sterilization conditions and would be irreversibly damaged. Think of how poaching an egg changes its structure. For these fragile materials, aseptic processing is used.

“Aseptic” means free of pathogenic (i.e., disease-causing) microorganisms. For this method, the different components of the finished drug form are each sterilized separately, then brought together and assembled under conditions designed to prevent the potential re-introduction of microorganisms. For example, the containers and closures (e.g., vials, syringes, cartridges, stoppers, caps) may be sterilized ahead of time using heat (either dry or steam heat). Product-contact materials such as bulk containers (carboys), filters, fill tubing, and fill nozzles, can similarly be heat sterilized. The actual drug ingredients, either individually or in a pre-formulated state, are usually sterilized through very fine specialized filters that have been proven to remove bacteria down to 0.22 microns from the product stream as it passes through the filtration media.

These components, separately sterilized, are brought together in a clean room. These rooms have controls such as HEPA (High Efficiency Particulate-free Air)-filtered air to remove bacteria in the air, higher pressures to keep outside air out, and strict controls on operator dress and behavior, that together help to ensure that no microorganisms can be introduced into the product by the operator. In the clean room, the sterile containers are filled with the correct amount of product and then sealed to protect them from future contamination.

A number of additional controls go into ensuring that clean rooms stay “clean”. These rooms are routinely certified to demonstrate that they are performing according to their design. Environmental monitoring is performed during every product batch to make sure that the proper environment is maintained. Operators entering the clean room are highly trained in proper gowning and behavior, and must pass a test before initial entry and routinely thereafter. The aseptic filling method is challenged periodically to ensure that there is nothing within the process that could result in a sterility failure. The entire process is simulated during these challenges, and a special growth media designed to show the presence of any microorganisms within the product container is used. Samples are taken from the operator’s hands and gown in search of microbes. A zero “positive” result is the expected result.

Aseptic processing is an established and well-controlled method for producing quality, sterile drug products. Manufacturers conform to strict guidelines and requirements set forth by regulatory agencies such as the FDA. This method is crucial for manufacturing many of the most critical medicines used to treat diseases in the modern world.

 

 

 

How Pharma Uses “Smoke Studies”​ To Help Keep Employees Safe During The Pandemic

In early 2020 many industries opted for remote working. Afton Scientific knew that this was not an option. We needed to remain open to produce life-saving drugs. The challenge was to prevent community spread should one employee become infected.

Early on we implemented standard safety protocols, such as:

  • Twice daily temperature checks
  • Mask protocols
  • Hand sanitizing stations
  • Employee education
  • Outdoor morning meetings

 

 

 

The nature of pharmaceutical manufacturing often requires employees to work in close proximity for long periods. We asked ourselves how we could minimize the virus spreading in the air to other masked employees.

Air flow patterns in cleanrooms are designed to assure sterility by observing the sweeping of airborne micros and particles away from important areas with controlled air flow. Smoke studies are conducted to observe those air flow patterns.

We applied the same air flow analyses in non-sterile work areas to determine:

 

  • Where targeted airflow would be helpful
  • Where to add plexiglass panels.

 

 

 

 

For example, in our inspection rooms operators work in close proximity. Based on the path of the non-toxic smoke we added ductwork to give each workstation its own air supply. Then we followed the air to a safe capture location.

 

 

 

 

Thick plexiglass panels were also added between each station and operators are masked at all times.

 

 

 

 

While a few of our staff have become infected with COVID outside of work, each was an isolated incident and there has been no community spread among any employees.

According to CDC and Virginia guidelines, with each positive result (less than .5%) we conducted internal contact tracing and determined which employees required testing and quarantining. In all instances tests were negative and employees were able to return safely to work.

As an essential business we are now well on our way to having our staff vaccinated. We will continue to mask and observe best-practices while looking forward to the next new normal.

Afton Scientific Statement on COVID-19

Afton Scientific Statement on COVID-19

At Afton Scientific, we understand your concerns with regards to the novel coronavirus pandemic and how it will affect our products and services. Afton is actively monitoring the situation and will provide updates as any new information becomes available.

Afton’s number one priority is the health and safety of our employees, their families, and our community while also continuing to provide support to our clients and partners. With that in mind, we have implemented the following measures to help ensure health, safety, and business continuity for our team and network:

  • Limiting on-site visits
  • Enhanced cleaning, hand sanitization, temperature monitoring, and exposure reporting
  • Promoting social distancing where possible and requiring face masks where not possible
  • Modified workspaces with barriers to help promote distance
  • Increased communications with suppliers and monitoring any changes in lead times
  • Identified critical raw materials and secured additional inventory, as appropriate
  • Monitoring the supply of critical PPE for both manufacturing and common areas

Our responsibility to our clients and partners is to continue providing quality products and services. Afton’s facilities are continuing operations and manufacturing activities are proceeding as scheduled, with the above safety measures in place. We are in constant contact with our suppliers to ensure that critical raw materials are available and to mitigate any potential impact to our supply chain.

Afton will continue to monitor the guidance provided by the Center for Disease Control and World Health Organization and adapt as appropriate. Please Contact Us if you have any questions.