Aseptic processing has been in commercial use since the 1950s. Pharmaceutical products are one of the most sensitive necessities that can get easily contaminated during production.

Pharmaceutical manufacturers require sterile products, which was not possible with autoclave sterilization methods. Aseptic manufacture standards address sterility and sterilization for both heat-sensitive and non–heat sensitive pharmaceutical products.

Aseptic pharma processing technique runs on the wheels of a well-controlled and well-maintained environment instead of terminal sterilization.

The global aseptic pharma processing market was valued at $10,633.3 million in 2020 and is expected to reach $24,364.0 million by 2031, witnessing a CAGR of 7.90% in 2021-2031.

The growth of biopharmaceuticals and generics has mainly driven the pharmaceutical sector. Another reason for the rise in the aseptic pharma processing market is that biotech companies continue to make massive investments in improving already existing technology.

What is aseptic pharma processing?

While producing a product, there are high chances that bacteria might contaminate the product. Sterilization and aseptic pharma processing methods are used to eliminate the probable bacterial contamination in the manufacturing units. It is a healthy manufacturing practice strictly followed by those businesses that deal mainly in pharma and pharmaceutical-related products. Besides offering a sterile environment for manufacturing pharma items, aseptic pharma processing provides a perfect alternative to sterilization.

In terminal sterilization, where heat is concerned, the products or pharma medications are sterilized by providing heat.

How to maintain the aseptic conditions in pharmaceutical companies?

Every manufacturing unit is advised to follow certain protocols and safety norms to create a sterile environment for safe pharma products production.

All the personnel undergo workshops, drills, and mandated training procedures to ensure hassle-free and quality production. Specific written rules are provided along with ‘clean-room’ behaviors to follow.

The air quality of the product manufacturing room is controlled to prevent contaminants from entering the room. The equipment and the rooms are regularly sanitized; the activities are supervised to ensure the utmost safety of the products. The humidity, pressure, and ventilation system are also monitored under aseptic pharma processing.

Why use aseptic pharma processing?

Companies and manufacturing units often use sterilization to eliminate the possible bacteria on the surfaces of the products. However, constant sterilization slowly becomes ineffective in the long term because of its harsh processing conditions. Therefore, the requirement of full-fledged aseptic pharma processing becomes a necessity at this point. As compared to terminal sterilization, aseptic pharma processing provides an already sterile environment where the product can be manufactured. In this way, the overall safety and effectiveness of the product are retained. The companies are supposed to follow set norms to facilitate good manufacturing practices and prevent unsanitary conditions.

While the absence of acknowledged masses and skilled labor certainly are problems, the same can be solved by fully implementing the aseptic pharma processing.