Witt’s Chicago plant expands Witt’s development services. The Witt Company based in Ravensburg, Germany, is an independent, international, specialized agency, contract developer and manufacturer of sterile pre-filled syringe systems, injection cartridges and vials, in high-quality sterile pre-irrigation The injection system has more than 25 years of production experience.
A new type of glass bottle filling system is at the site of Witt’s US work. The company’s full name is Chicago-based Witt Development Services (USA) (VDS), one of the world’s most advanced sterile clinical preparation operating systems. The core of the operating system is a glass bottle filling machine model MHI 2020B supplied by Bosch Packaging Technology Co., Ltd. It is a unique machine developed exclusively for sterile clinical preparations, allowing highly automatic glass bottle filling. Fitting and capping, especially for low-dose drug filling.
The operation includes a one-time system and a restricted access barrier system (RABS), which greatly reduces the risk of drug contamination. The system integrates glass bottle filling, rubber stoppers and aluminum caps.
Thomas Otto, Victor’s CEO, said, “At the Witt Chicago factory, we focus on the manufacturing of pre-clinical to second-phase early products, after which we will mass-produce and transfer it to our commercial manufacturing plant. Three stages of filling and market production were carried out. To ensure seamless interfacing with commercial manufacturing, we replicated commercial processes at the early work site (Chicago)."
A new automated production line at the Witt company's Chicago plant for the filling of frozen or liquid products (up to 10,000 units/batch). Its monitoring system integrates the filling and capping process. The production line can handle sizes from 0.1 mL to 23 mL. Glass containers.
The restricted access barrier system (RABS) provided by Bosch is a rigid wall enclosure equipped with a HEPA filter capable of filtering unidirectional air, and can obtain the grading space specified by the ISO5 standard. All air handling equipment is built into the system, and glove machines, sleeves and gloves are all fixed to the wall. Witt’s operators are not allowed to enter RABS during normal operations and all operators’ activities are performed through glove machines. The RABS on site at the Wit Chicago factory was placed in a 10,000-class area and the system itself was rated as Class 100 clean room.
The vials used for the operation are sterilized by an autoclave and sent to a turntable in the RABS system. The vials are placed in a single row on a conveyor belt. After leaving the turntable, they are sent to the collection point and the handling unit picks up once. Two bottles are then turned back onto the weighing device.
The rubber stopper is provided by a vibratory bowl, which is conveyed downwards from the conveyor belt to the processing unit where the two stoppers are collected and placed on top of two bottles still remaining in the filling area, and then the joystick is tilted downwards to stop the stopper. Tightly in place. If the filling machine is operating a lyophilized product, the joystick is only partially seated in a lyophilized special stopper.
The vial processing unit then collects the vials and places them at the next stop for capping. Similar to the stopper, the cover is sent from the vibratory bowl from the chute to another processing unit to collect the two caps and place it on top of the two stoppers.
The caps themselves carry aluminium skirts, which are then conveyed to another station, where they are counter-rotating with the oncoming horizontal wheels, thereby tightly rolling the aluminium skirts onto the bottles.
After the weighing device weighs each empty bottle, the filling nozzle drops and fills the product until the weight of the product in the bottle reaches the set weight value, and the filling is finished. The precise weighing system can be programmed to set different filling quantities and different products, and the filling process is controlled 100%.
Disposable part
The product enters the bottle through a peristaltic pump or a rolling diaphragm pump from the tank pump. This type of pump and its related products are equipped with one-time contact accessories, thus eliminating the need for cleaning verification and avoiding contamination caused by excessively long periods of contact with the product's accessories. With each product flow, all equipment that comes in contact with the product is disposed of, which avoids contamination of the next product.
Bosch can supply peristaltic and rolling diaphragm pumps as well as PreVAS disposables, which are sufficient for use.
The PreVAS series of sterile disposable dosing systems is a fully pre-assembled and pre-sterilized dosing system supplied with validation documentation.
This allows risk-free filling operations to be expanded in a one-time model. PreVAS eliminates complex cleaning procedures and verification protocols, allowing the entire system to be quickly installed and operated at the time required by the previous system.
The vials were unloaded in parallel lanes and unloaded onto a conveyor belt at a right angle.
Lyophilization
Individual products need to be lyophilized, another way of saying freeze-drying. Freeze-drying is a method of removing liquid reactants to support stability selection. Freeze-dried products will have a significantly longer shelf life than liquid drugs.
By freezing the drug and reducing the surrounding pressure, the frozen water in the material is directly sublimated from the solid state to the gaseous state to achieve the goal of freeze-drying. This method is particularly suitable for heat-sensitive products because the heat cannot act on the dried product.
At Vette, vials were dispensed from the filling line after pressurizing the stoppers by lyophilization. In order to evacuate water vapor, there is a channel water supply steam escape around the freeze-dried bottle stopper. In addition, the stopper did not fully press into the vial.
The vial was pushed onto the adsorption platform mounted on the side of the RABS. When filling is complete, the operator pulls the accumulated vials into a tray and stuffs them into the lyophilizer. In Witt, the device supplied by Hough Special Engineering Inc. is capable of loading 10 pallets on a five-story rack.
After the two trays in the first level are jammed side-by-side, the device automatically lifts them so that the other two trays can be jammed into the next layer. This operation was repeated until all 10 trays were jammed in, after which the device was closed and the chamber was evacuated.
Usually, the process takes one to four days (depending on the prescription and filling volume) to complete the lyophilization, and a solid product called lyophilized cake will appear inside each bottle.
The vial containing the lyophilized cake is returned to the feed turret and into the production line. The vial bypasses the fill and stopper insertion steps, and the operation returns to the joystick drop point to advance the stopper into the vial.
Ott said, "Vite is the first company to use Bosch's new systems designed for clinical stages and high-priced drugs. Bosch filling machines use all disposable, drug-contact accessories to eliminate the need for cleaning validation. This saves valuable time and costs."
Ott continued, “This is a compact machine with a minimum length of pipe to increase the production of API (active pharmaceutical ingredient), which is particularly important for high-priced products manufactured by Vital for its customers. The value of a 1 liter API can easily exceed one million U.S. dollars, and this is likely to be the result of several years of efforts by a biopharmaceutical R&D team.The machine contains a 100% weight check system, and this is largely Because, if the amount of drug in the vial is inaccurate, it may affect the clinical research results, especially small-scale early tests."
Extended automation
Witt's production line has taken clinical manufacturing and R&D to a new level. The MHI2020B allows self-monitoring and self-contained filling operations. The degree of automation is extended to a high level of safety for filled medicines. The production line also possesses the process control of transportation and processing as well as the automatic processing functions of filling and capping.
Glass bottle filling is highly accurate, and the conditions of the capping also meet the classification criteria of the clean room. This not only increases the protection of drugs, but also protects the participants of clinical trials and makes an important contribution to the successful completion of early drug development. . The quick and flexible use of various disposable systems allows Wit to effectively adjust manufacturing procedures to meet the requirements of different drugs.
The development of new clinical drugs is a key challenge for the international pharmaceutical and biotechnology industries. The growing competition and higher R&D costs put pressure on innovation portfolios, government regulations on quality and safety – all of which require an effective solution.
Therefore, the combination of efficient international standards and optimization time - between markets is the key. Typically, drug candidates are produced in complex laboratories and are manufactured in limited quantities. In addition, many drugs are complex compounds that are extremely sensitive to the environment.
Witt’s pharmaceutical manufacturing pipeline in Chicago provides a solution to the economic and technical requirements of clinical development. The facility can operate small-scale filling tests in a more efficient and safer manner during the preclinical to second-period period.
The use of a one-time filling system kit makes the preparation of each filling faster and safer, and also reduces the complexity and cost of the preparation period. Development studies (compatibility, informal stability tests) can be realized on-line in small-scale filling; the use of pipes and pumping systems is particularly protective of the product, as well as the automation of the product through the process, enabling Witt to achieve exceptionally high The result of processing.
Few samples are eliminated to avoid the destruction of process control (IPC) tests and reduce tube losses, all of which contribute to the effective reduction of active drug losses.
The production line has reached international standards, making the number of candidate drugs available more productive and saving valuable time and money.
In addition to the automated vial line, the 24,000-square-foot Chicago facility also includes a second clean room to semi-automatically fill different drug delivery systems. There are also chemical analysis laboratories, microbiology laboratories, material preparation and synthesis functions, visual inspections, cGMP (Dynamic Drug Production Management Specification) storage areas, and administrative offices.
In general, the factory allows the company to provide a package of services around the clinical R&D of injectable drugs to provide customers with services ranging from pre-clinical R&D to second-phase trials. As for Phase III and commercial manufacturing, the Chicago factory provides products that seamlessly interface with Witt's large manufacturing facilities in Europe.
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