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Overview of sterile drug product manufacturing services & more on leading CMOs, CDMOs offering aseptic processing, sterile fill finish, etc.

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Overview of sterile drug product manufacturing services & more on leading CMOs, CDMOs offering aseptic processing, sterile fill finish, etc.

Q1. What is a sterile drug product and when is sterile fill-finish required?

The pharmaceutical industry defines sterile drug products as dosage forms of a drug that are essentially free from living microbes and chemical or physical contamination to the point at which it poses no present risk to the patient, in accordance with regulatory standards.

Sterile products are administered via an enteral route of administration such as the intravenous, subcutaneous, or intramuscular route. As these complex drug products are infused directly into the bloodstream or body tissue, it is extremely important that they are sterile. Sterile dosage forms include, but are not limited to sterile liquids, parenterals (injectables), surgical irrigants and ophthalmics.

As sterile dosage forms are intended to be delivered via enteral routes of drug delivery, they bypass various natural defence systems of the body. Therefore it is essential for these pharmaceutical products to undergo sterilization. 

Sterilization is the use of a physical or chemical procedure to destroy all microorganisms including large numbers of resistant bacterial spores. All sterile drug products have to undergo sterilization before they can be distributed to consumers.

Sterile fill-finish is the area where a sterile drug is transferred from a filling needle to a sterile container, usually a vial or prefilled syringe. Normally, the stoppering of a container happens after, with the exception when a drug requires sterile lyophilization. 

In sterile fill finish, before aseptic assembly into a final product, the individual parts of the final product are generally subjected to various sterilization processes such as filtration, dry heat sterilization, lyophilization, etc. 

Fill-finish operations have traditionally been among the most commonly outsourced biopharmaceutical sterile drug product manufacturing activities. Consequently, there are various pharmaceutical organizations, including contract development and manufacturing organizations (CDMOs), that offer the manufacture of sterile pharmaceutical products.


Sterile fill-finish is required for various reasons, some of them are noted below:

- Drug products that are delivered via the parenteral, ophthalmic, inhaled, or otic route present an increased risk of infection or harm because they bypass many of the body's natural defenses.

- To ensure patient safety, the FDA requires that drug products delivered via these routes be supplied as sterile products. 

- Processes like sterile fill-finish ensure that drug products are sterile and safe for consumption.

Q2. How are sterile drug products produced by aseptic processing?

Aseptic processing is defined as the handling of sterile products, containers, and devices in a controlled environment, in which the air supply, materials, equipment, and personnel are regulated to maintain sterility. Aseptic processing involves sterile processing techniques, cleanroom facilities, drug product components and container systems, etc. 

Aseptic processing encompasses various sterile drug manufacturing techniques that go into ensuring that a drug product is free of contaminants, thereby reducing the risk of infection to the patient. It entails the processing of drug components, drug product containers, and excipients in a manner that precludes microbial contamination of the final sealed product.


- Processes 

As exposed products are vulnerable to contamination a lot of care needs to be taken when conducting sterile processing techniques. It is imperative to practice good aseptic sterile drug manufacturing techniques and contamination control throughout the manufacture of sterile injectables.

Aseptic fill finish is the area where a sterile drug is transferred from a filling needle to a sterile container, usually a vial or prefilled syringe. Normally, the stoppering of a container happens after, with the exception when a drug requires sterile lyophilization. Alternatively, terminal sterilization is the process of sterilizing a product in its final container. Terminal sterilization is an important process as it ensures the product remains sterile.


- Cleanroom Facilities

In simple terms, a cleanroom is a controlled area within a wider facility that maintains a specific level of air particles and other contaminants. A cleanroom is a controlled environment that defines personnel access, levels of contamination, pressurization, and temperature and humidity. The cleanroom suite comprises multiple rooms with varying levels of control.

Each process could introduce an error that ultimately could lead to the distribution of a contaminated product. Any manual or mechanical manipulation of the sterilized drug, components, containers, or closures prior to or during aseptic assembly poses the risk of contamination and necessitates careful control and cleanroom facilities


- Drug Product Components and Container Systems

In aseptic processing the drug product, container, and closure are first subjected to sterilization methods separately during aseptic manufacturing, as appropriate, and then brought together. Because there is no process to sterilize the product in its final container, it is critical that containers be filled and sealed in an extremely controlled environment under current Good Manufacturing Practices. This is referred to as sterile fill finish or aseptic fill and finish. Each of these sterile drug manufacturing techniques requires validation and control.

Traditional sterile processing techniques allow a final sterile drug product to be achieved by individually sterilizing the containers, material and equipment in-process, resulting in a unified sterilized product. Aseptic processing thus handles components, materials and equipment in such a manner that foreign microbial and endotoxin contamination that exceed predetermined acceptable levels, are not introduced to the product stream.

Q3. What are the control strategies for the manufacturing of sterile pharmaceutical products?

A control strategy for manufacturing sterile pharmaceutical products and substances sets out a documented approach and rationale taken to control a product's quality and efficacy as well as patient safety. An effective strategy takes various factors into consideration. 

These factors may include the type of pharmaceutical product being manufactured, microbial contamination, sterility assurance, facility design, chemical contamination, particle contamination, viral control and other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations. 

Pharmaceutical organizations, such as a CDMO or CMO, which offers sterile manufacturing services have extensive experience in producing sterile pharmaceutical formulations. They incorporate the above given controls into their sterile manufacturing service offerings. 


Some Control Strategies for the Manufacturing of Sterile Pharmaceutical Products:


- Manufacturing Control Strategy 

A manufacturing control strategy for sterile products depends on the product type, demand, process and risk associated with it. The manufacturing control strategy should identify a defined approach on how a specified level of control will be achieved and implemented during the sterile manufacturing process.


- Contamination Control

Contamination control is another important parameter when it comes to the manufacture of sterile pharmaceutical products. A contamination control strategy requires a holistic identification, assessment, control and monitoring process for contamination risks that include microbiological, particulate, chemical and cross product contamination.


- Microbial Control Strategy for Environmental Control

A comprehensive microbial control program should identify the risk of contamination to the product as well as the different mitigation steps to control this risk. The systems used to control the environment of the facility are qualified prior