Tofflon Containment Capsule Filling Machine: The "Safety Shield" for High-Potent Drug Production

In the pharmaceutical industry, the production of high-potent drugs (such as anti-cancer drugs, targeted therapies) consistently faces a "dual challenge": ensuring precise drug dosage and stable quality while strictly preventing powder leakage from harming operators and the environment. With the implementation of OEL (Occupational Exposure Limit) standards in global, creating a "zero-leakage" production environment has become key for pharmaceutical companies to advance the industrialization of high-potent drugs.

With years of deep expertise in OSD equipment, Tofflon has developed the TCF series containment capsule filling machine to address the pain points in high-potent drug production. Built on three core technologies — "Negative Pressure Isolation + Fully Contained Process + Intelligent Control"— it acts as a "safety shield" for high-potent capsule manufacturing.

Why Choose a "Containment Capsule Filling Machine" for High-Potent Drug Production?

High-potent drugs contain extremely high concentrations of APIs. Even minimal powder leakage can pose health risks to operators and potentially contaminate the environment or cause cross-contamination with other products. Traditional capsule filling machines, with their open or semi-open designs, are prone to powder escape during operation, making it difficult to meet the stringent requirements of OEB 4~5 levels.

Tofflon TCF series containment capsule filling machine solves the "leakage" challenge from the design stage. The working chamber maintains a stable negative pressure of -50Pa to -100Pa, coupled with an H14 high-efficiency filtration system, achieving filtration efficiency >99.995%. This ensures "zero powder leakage" throughout the process, safeguarding operator health and complying with the latest GMP requirements.

Figure 1：TCF120WIP Capsule Filling Machine

Three Core Technologies: Revealing the "Zero-Leakage" Cutting-Edge Technology

1. Negative Pressure Isolation Chamber: Guarding Every Capsules like a "Protective Shield"

The heart of Tofflon's containment filling machine is the negative pressure isolation chamber. It features a "stainless steel hard-wall + inflatable seal" design. All chamber seams are fully welded using TIG welding, and surfaces are polished to eliminate any sanitary dead ends. Inflatable gaskets seal the viewing windows to the frame. The chamber is equipped with both electronic and mechanical interlocks to ensure complete airtightness under normal conditions. Even during unexpected events like power failure or emergency stops, the gaskets remain inflated, preventing any risk of leakage.

2. Fully Contained Process: From Feeding to Discharge, "No Leakage, No Exposure" of Material

"Leakage risk points" in high-potent drug production often lie in material transfer and auxiliary equipment connections. Tofflon TCF series containment capsule filling machine integrates upstream and downstream process equipment to achieve “Full-Process Contained Connection”:

Feeding: Utilizes a hoist + IBC with an α-β valve (split butterfly valve). The hopper connects seamlessly to the machine during feeding, with zero dust leakage upon separation.

Auxiliary Connection: Matching auxiliary equipment like the capsule polisher and metal detector are designed with the same containment level and connected to the main machine via contained pipes, preventing material exposure during transfer.

Sampling: Features an integrated sampling port. Sampling is performed using a "continuous bag-in-bag" method, ensuring no powder escape.

Dust Collection: Equipped with a BIBO dust collector. Filter replacement follows the "Bag-in/Bag-out (BIBO)" method, protecting operators from harmful dust during filter changes.

Figure 2: TCF420WIP Capsule Filling Machine and Containment Polisher & Metal Detector

3. Intelligent Control + Online Washing: Safe and User-Friendly

To reduce risks associated with manual operations, Tofflon TCF series containment capsule filling machine is equipped with a Siemens control system and features the following intelligent functions:

• Real-time Monitoring: The screen dynamically displays parameters such as chamber negative pressure, filter differential pressure, and production progress, with automatic alarms for abnormal pressure.

• Permission Management: Three-level user permission settings prevent misoperation and comply with FDA 21 CFR Part 11 data traceability requirements.

After production, the equipment supports online washing: simply seal the dust collection pipe port and use the built-in water gun to rinse internal components like the working chamber, dosing disc, and filling rods. The waste water drains through the tabletop drain outlets, preventing dust residue. After washing, a quick dry can be achieved using an air gun, significantly reducing cleaning time and improving equipment utilization.

Figure 3: Isolator Integrated Washing in Place System

Going Beyond “Safety” to Deliver Both “Efficiency” and “Flexibility”

Tofflon TCF series containment capsule filling machine maintains high production efficiency and flexibility while ensuring safety:

• Efficient Production: Features a dosing disc design with a capacity range from 7,200 capsules/hour to 42,000 capsules/hour, meeting the production needs of most pharmaceutical companies for high-potent drugs.

• Flexible Adaptation: Supports capsules from size 00# to 5#. Filling parameters can be adjusted according to drug characteristics, adapting to various high-potent drug recipes.

• Optional Configurations: Options such as a polisher and metal detector, online fill weight checking, and vacuum conveyors can be selected based on production needs to create personalized production solutions.

Customer Testimonials: Seamless Compliance from Lab to Scale-Up

So far, Tofflon TCF series containment capsule filling machine has already been in service for several domestic anti-cancer and targeted therapy drug manufacturers, as well as overseas pharmaceutical companies in countries like Iraq and Saudi Arabia, helping them deliver products to the market swiftly.

In the current landscape of accelerated R&D and production for high-potent drugs, the "compliance" and "safety" of equipment have become one of the core competitive advantages for pharmaceutical companies. Tofflon consistently adheres to the "Quality by Design (QbD)" philosophy, starting from user needs to continuously advance containment technology. In the future, Tofflon will continue to deepen its expertise in the field of OSD equipment, providing more pharmaceutical companies with "safe, efficient, and intelligent" containment production solutions so as to make high-potent drugs available to patients sooner.