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The Challenges Faced by the Aseptic and Sterile fill and finish Industry

25 April 2022 | News

The Aseptic and Sterile fill and finish underwent testing times during the pandemic. However, this industry has been constantly under pressure because of the limited availability of aseptic processing for new products. Whenever a company developed a new drug, it had to wait for longer timelines.

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The pressure mounted in the aseptic and sterile fill and finish industry when the pandemic hit. The pharma industry had to outsource to CDMO to fulfill their promises. It increased pressure on ATMP companies which now had to plan their independent fill-finish capacity. 


The concerns for fill-finish availability for pharma companies indulged in biologics, generics, or biosimilars are ever-rising. Moreover, the drug shortages and timeliness enhance the burdens. 


Even with the modern technologies, the challenges in the aseptic industry are rising. And with a higher number of small-batch targeted biologics entering the markets, one can expect more complexity. 


Top Challenges Faced by the Aseptic and Fill and Finish Industry

When working the biologics, numerous aspects must be carefully perused. The aseptic and sterile fill and finish industry require processes that work with precision. Let’s peruse the top challenges they face:

#1: Sterility

The sterility of the product is one of the industry's prime concerns and comes with great challenges. Ensuring precision during the sterility process is of utmost importance since a minor breach can devastating impact. 


When the contaminated batch is put into the market, the patient's safety is at peril. Therefore each fill and finish needs to ensure an extensive level of inspection and maintain strict criteria for acceptance. With the availability of sophisticated equipment, the precision in sterility has improved, but it continues to be a number one challenge for this industry. 

#2: Filling Precise Doses

Vaccinations and other vital drugs must be administered in specific doses to the patients. The accuracy of filling is another major challenge faced by the fill and finish industry because mis-dispensing can result in traumatizing events. 


The use of high-end and sophisticated equipment is important to ensure that only the required level of filling is done. At the same time, it must be ensured that no accidental spillages occur as they may become homes to microbes that thrive to survive in a wet environment.

#3: Regulatory Compliance

The Food and Drug Administration (FDA) defines and inspects aseptic as well as fill and finish production to tight regulatory criteria. These requirements can't be met until process monitoring criteria and fill-finish production safeguards are met. 


Regardless of the batch size to be filled, the monitoring mechanisms and protections apply to all fill and finish processes. 


Fill and finish protections reduce contamination, increase productivity and accuracy, create electronically auditable data, and identify contaminations early, reducing batch rejection time and financial implications. Inline process-controlled instrumentation is one of the most important safeguards for fill-finish operations.


Concluding Thoughts

The aseptic and fill and finish industry is expanding exponentially. Proper coordination, risk management, and regulatory compliance would become crucial. 


To overcome the challenges of the aseptic and fill and finish industry, it is important to stay equipped with the proper equipment and rely on the expertise and innovative technologies. The road ahead for these sectors would be more challenging and require a well-planned response. 


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