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Maker - Product Challenge

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Batch

When working with Cell and Gene therapies, precise and sterile filling processes are critical. Challenges often include maintaining aseptic conditions, minimizing cell stress, and controlling fill volumes to ensure product integrity.
<h2>Facilitates aseptic filling of cell and gene therapy products</h2>
The ValueCell FILL by Comecer is a semi-automatic filling system specifically designed for the Cell and Gene therapy fields. This system supports downstream aseptic bag filling operations, offering a closed and modular solution. It includes a refrigerated storage area, a distribution rack, and a peristaltic pump filling system, ensuring low shear stress for sensitive products. The ValueCell FILL is compatible with Grade C cleanroom environments, and its reverse pumping feature minimizes product loss. It is equipped with gentle paddle mixers for ensuring a homogeneous mixture and in-line bubble sensors for quality control. The system handles fill volumes ranging from 50 to 250 mL, with a capacity of up to 150 bags per hour. Ideal for dispensing viral vectors, final cell products, intermediates, and media, it also offers scalable batch sizes to match production growth and includes an intuitive touchscreen HMI for easy operation.

Semi-automatic filling system for cell and gene therapy

Control

Filling lines are used extensively in all industries, such as food, pharmaceutical, chemical, and cosmetics, to accurately package different products into a container suitable for that product. Although the filling process is at the very end of the production line, it is no less important than the earlier steps. Last but not least, the idiom that dates back to 1382 when John Wyclif wrote the firste the laste, and the laste the firste, indicates just that the last things on a list are just as valuable as the previous ones. In this case, this idiom fits perfectly.

Filling

Industrial mixing equipment is used to combine two or more solid, liquid or gaseous segregated ingredients into a homogenous single product. The choice of mixing technology depends largely on the physical state of the ingredients and the desired final product. But the sensitivity of the ingredients, the process temperature, and pressure requirements are also critical factors. All these parameters result in a wide range of industrial mixers.

Mixing

Quality control

liquid

Industrial

Scaling up manufacturing for cell and gene therapies often requires precise aseptic filling solutions. Common challenges include maintaining sterility, ensuring accurate fill volumes, and minimizing contamination risks, which are critical to adhering to GMP compliance.
<h2>Ensure high sterility and precise filling</h2>
The Cellana XL1 by Aseptic Technologies is a specialized aseptic filling system designed to handle the precise and sterile filling of gene therapy products, including viral vectors and plasmid DNA. This system utilizes isolator technology to provide high sterility assurance and GMP compliance. Single-use materials minimize the need for batch-to-batch changeover, ensuring efficient and flexible operations. Capable of filling volumes from 0.1 ml to 50 ml at rates up to 700 vials per hour, the Cellana XL1 offers high filling accuracy with 100% in-process weight control (IPC). Additionally, it features a rapid decontamination airlock that completes in under 20 minutes, and it is designed for grade C installation environments. Full compatibility with other isolated modules of the Cellana series further enhances its utility in comprehensive manufacturing workflows.

Aseptic vial filling system for gene therapy products

Decontamination

Industrial sterilization processes are employed in different industries to completely eliminate all living microorganisms from the final product. For instance, in food processing, sterilization equipment is used to produce a stable product with a long shelf-life by eradicating harmful bio-contaminants. Instead, in the medical field, sterilization technologies aim to prevent the transmission of microbes to patients by sterilizing all the tools and medical devices that come in contact with the patient. Most sterilization equipment, such as autoclaves, employs high-temperature pressurized steam to destroy bacteria and disinfect surfaces from spores. Other methods include radiation sterilization or using chemicals such as hydrogen peroxide for disinfection.

Sterilization

In nuclear medicine, there is a critical need for reliable production of Tc-99m generators, crucial for diagnostic imaging. Traditional manual methods are inefficient, subject to human error, and pose significant safety risks due to radiation exposure.
<h2>Automates tc-99m generator production under Gmp conditions</h2>
The Tc-99m Generator Production Plant by Comecer is a semi-automatic line designed for the efficient production of 99mTc generators, adhering to GMP standards. This production line features 12 working chambers with lead shielding of either 100mm or 150mm. The plant automates several processes, including 99Mo formulation, automatic filling, and washing of generator columns, and in-line QC for 99Mo breakthrough. With its progressive-shielding chambers, it ensures operator safety through all stages, from loading high-activity bulk to final QC operations. The double pass-through autoclave allows for efficient transfer and sterilization of columns, ensuring productivity even during autoclave maintenance. The production line is capable of producing 250 generators every 12 hours, with operations scalable to three batches per week.

Technetium-99m generator production line

Formulation technologies are an integral process in many industries such as pharma and food. Chemical mixtures require strict handling to combine the separate ingredients into the homogenized recipe that makes your final product. Formulation technology stores, mixes and subjects the elements to a range processing parameters according to your specifications to develop the base material. The resulting formulas are then weighed, formed, packaged, or sent for further formulation.

Formulation

Industrial washing systems are used to clean and disinfect a variety of items in research and manufacturing facilities. Industrial washers use solvents and cleaning agents with mechanical action to remove deposits and residues from stainless steel machinery components, empty containers, and other soiled surfaces. The selection of an industrial or commercial washer depends on the type of items and surfaces to be cleaned, the type of deposits/residue that is typically present, whether drying is required after rinsing and the level of sterilization necessary. Manufacturers will have cleaning specifications and as a result, require washers to be engineered to meet these specs.

Washing

solid

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Control Technologies

Which control equipment technology do you need?

Semi-automatic filling system for cell and gene therapy

Aseptic vial filling system for gene therapy products

Technetium-99m generator production line

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