(1)The filling machine is the core equipment of the vial production line and widely used in sterile injection, cosmetic medicine, oral liquid, freeze-dried powder and other fields. It can be said that other equipment of the vial production line is equipped for this machine.
(2)The machine's construction and materials comply with GMP standards. The parts in direct or indirect contact with the product such as filling needle and stopper hopper are made of stainless steel 316L or medical-grade silica gel, while non-contact parts such as exterior parts and laminar flow supports are made of SS304 or POM.
(3)An O-rabs system is equipped, which includes class A laminar flow, glove ports, and interlocking safety doors, and door-opening alarm to restrict operator's operation and access; it also has built-in ports for dust particle, airborne viable bacteria, and air speed detection.
(4)The equipment is designed for excellent stability. The high-precision servo motor or speed regulating motor is adopted for the moving parts, which has simple structure, low failure rate and more stable operation.
(5)With alarm and shutdown function: in case of abnormal phenomenon in operation, it can give an alarm and stop running in time, display fault point, and record and export various data when fault occurs.
(6)We use international first-class electrical brand with long service life and stable performance.
(7)The adopted rotary stoppering is stable and high-efficient with fast speed. It also has function of no bottle no stoppering.
(8)With multiple detection stations such as stoppering overload protection, stopper missing detection, filling overload protection, out-pf-limit air speed of dust particles, it greatly reduces abnormal conditions which affect normal production.
(9)It has high filling accuracy. The full servo control is adopted for the filling system, the filling volume of each pump can be adjusted independently, and the optional online weighing system can realize the self-calibration of the pump.
(10)The ceramic plunger pump used is more wear-resistant. The equal-volume filling principle is adopted to make filling volume adjustment more precise.
(11)It has the function of sucking back which prevents overflow, and never drops extra liquid medicine.
(12)During filling, the needle remains in contact-free with the liquid surface. The insertion depth rises synchronously with the liquid level, maintaining a relatively stationary synchronous movement to avoid liquid splashing.
(13)The software system complies with GMP and FDA CRF21 part11 requirements. It can be equipped with an international premium brand's IPC and an audit trail system that tracks key operations during the production process, records specific details such as date, time, operator account, operation content, and notes. The system features a 4-level user access setup, including different levels for operators, technicians, managers, and maintenance personnel.
(14)Each account can be set up at least 50 operators, and each with a unique password and customizable name.
(15)The operation on the HMI is simple and convenient, with its bilingual interface and ergonomic structure design. Its control system can achieve fully automatic operation of production, monitoring, detection and recording; with recipe generation and storage functions, it supports one-button calling of production parameters.
(16)It adopts modular design, with good compatibility. It is applicable for various filling volumes and methods by replacing change parts. It also can be used alone or connected with labeling machine, light inspection machine and other equipment to form a production line. The filling pump unit can be disassembled and replaced or expanded according to production requirements, and 12 pumps can be installed at most, which greatly improves the equipment capacity.
(17)The machine offers a high degree of customization with a variety of optional functions. It can be equipped with nitrogen filling to stabilize and protect drugs; CIP/SIP also can be optional to save labor and time associated with cleaning and sterilization before and after production, and to reduce the risk of contamination during the transport of sterilization instruments; and online sampling and weighing functions that support multiple weighing modes can be added. Other specific requirements can be discussed and confirmed during technical consultations to find solutions.
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