In recent years, with the explosive growth of biopharmaceuticals such as antibodies, fusion proteins, and ADCs, research into their production processes has become increasingly in-depth and extensive. Aseptic production processes run throughout the entire biopharmaceutical manufacturing process, especially in the aseptic production of the final product. The key focus of our control over aseptic production processes lies in the various details and the practical steps involved.

As the final step in the biopharmaceutical GMP manufacturing, sterile preparation filling requires personnel with professional expertise and rigorous training, highly automated equipment that operates smoothly, sound design, and strict standards to ensure the quality of the final product. A high-standard aseptic assurance system runs throughout the entire complex, continuous production process.

First: Requirements for Personnel

For the manufacturing of sterile drugs, personnel are the greatest source of contamination.

Article 20 of the "Good Manufacturing Practice for Pharmaceutical Products (2010 Revision) Annex 1: Sterile Pharmaceutical Products" (hereinafter referred to as "New GMP Annex 1: Sterile Pharmaceutical Products") clearly stipulates: "All personnel working in the clean area (including cleaners and equipment maintenance workers) should be regularly trained to ensure that the operation of sterile pharmaceuticals meets the requirements.

1.1 Personnel training and personal hygiene

1.2 Good behavior standards in clean areas

1.3 Clothing management and changing confirmation

Second: Requirements for Materials and Consumables

In the production process of sterile pharmaceuticals, materials, as excipients or raw materials, are an important part of the drug. Their control over microbial limits and endotoxins is crucial in ensuring the drug meets the established quality requirements. Key consumables, particularly those that come into direct contact with the drug, also play an important role in controlling particles and microorganisms. Below, two aspects will be discussed: release testing and pre-use treatment control of materials and consumables.

2.1 Quality standards and release testing of materials and consumables

2.2 Pre-use treatment and control of materials and consumables

Third: Equipment-Related Requirements for Aseptic Control

For sterile preparation production, process equipment is one of the most important factors for aseptic assurance. The performance of the equipment itself and any malfunctions during operation can have either a positive or negative impact on aseptic production. The following discusses the control requirements for equipment in sterile preparation production from three aspects:

3.1 Equipment selection and design

3.2 Equipment maintenance and repair

Fourth: Requirements for Plant Layout and Design

There are multiple provisions in "Chapter 7: Plant” of the New GMP Annex 1 - Sterile Pharmaceutical Products, which stipulate that for the production of sterile pharmaceuticals, the plant must meet specific functional and layout requirements. This ensures that the production environment of sterile pharmaceuticals complies with GMP standards and meets the needs of drug production. The following discusses the basic compliance requirements for sterile pharmaceutical production in terms of plant layout and design:

4.1 Plant layout

4.2 Plant design

Finally: The Role of Aseptic Process Design in Aseptic Assurance

Aseptic process design plays a critical role in the aseptic control of biopharmaceutical production. A well-designed aseptic process ensures a high level of aseptic control during production. Below, the role of aseptic process design in aseptic assurance are discussed from two aspects:

5.1 Sterilization filtration and aseptic filling process design

5.2 Aseptic process simulation (APS)

In addition to the above control measures, a good aseptic production process also requires employees to continuously summarize, optimize, and improve from the daily practice. Continuous improvement can only be achieved by identifying risks during production and formulating corresponding corrective actions.

For more questions on aseptic manufacturing processes, please visit the official website of BioDlink or contact us.