Step-by-step Aseptic Processing

 

Step-by-step Aseptic Processing

Providing patients with safe, effective, and contaminant-free drug products is the central demand of the fill-finish process. Close coordination between facilities, equipment, personnel, and specialized equipment and capabilities is required in aseptic processing.

Today's article highlights the step-by-step approach in aseptic processing. Keep reading to learn more.

At Abbvie, we process over a million vials annually with an automated filling line. Your drug product’s fill and finish procedures can be suited with customized packaging and labeling.

 1. Preparation of Bulk Drug Substance

After the bulk drug substance reaches the production facility and is acknowledged by the quality control team, it is moved into storage. It remains there until its programmed filling date. Its quality is verified through end-to-end cold-chain structure and traceability.

Safety measures should include emergency power, redundant refrigeration system, notification procedures in case of failure, and 24-hour temperature monitoring.

2. Pooling/ Formulation

The next step in aseptic processing is pooling and formulation of the final medication in a formulation and compounding suite in large or smaller tanks. Usually, a facility requires between 1 to 6 rooms of equipment for the pooling and formulation process. Engineering measures such as monitoring particulate exposure and temperature control are used to guarantee the product’s efficacy.

3. Component Prep

In aseptic fill-finish, aside from having a sterile environment, all components and equipment must be sterile and free from fever-causing microorganisms – pyrogens. This includes:

* Crimp cap or stopper preparations

* Vial preparation

* Tools going into the isolator and filling line

* Syringe preparations

To sterilize equipment, various systems are available. Each technique has a different impact on possible contaminants, packaging materials, and processes. For sterilization to be achieved, the proper method must be chosen.

4. Sterile Filtration

In aseptic processing, this procedure is used to remove microorganisms. It is essential to use correctly sized filters to reduce loss of high-value biologics and hold-up. Peristaltic pumps have become the standard for many biologics filling processes because using them is more convenient to adjust flow speed, thereby preventing splashing and foaming.

  5. Aseptic Filling

Accurate filling practices prevent overfills or underfills. Overfills increase costs while underfills cause rejects. The tolerance of the filling procedures is easier to adjust than in the past. Types of filling include diaphragm pumps, peristaltic pumps, and time pressure fills.

6. Lyophilization

Freeze-drying or lyophilization in fill-finish manufacturing is used to steady formulations of delicate parenteral drugs. During lyophilization, maintaining an aseptic condition is a technical problem for manufacturers. This is because it involves mass transfer and complex heat processes. Sterile procedures are required to prevent contamination while unloading and loading the sterile dryer.

7. Inspection and Packaging

Container and product inspection is an essential part of the filling process. Inspection can be fully automatic, semi-automatic, or manual. Inspection processes detect any non-conformity, such as particulates within the container, container closure defects, or cosmetic defects.

Once the product is filled, finished, and inspected, the last thing to do is package it for shipping. When packaging, the product needs to be labeled, identified, and the container must be protected for shipment. All products have their unique packaging, which is specially designed for the container.

To learn more about our pharmaceutical fill-finish, how we can assist you with aseptic fill-finish, or steps to kickstart your drug product, feel free to reach out to us; we shall be more than pleased to support you.