In the pharmaceutical industry, precise liquid metering equipment plays a crucial role in quality control during the production process and product consistency insurance. Ceramic metering pumps, as an advanced solution for liquid transfer measurement, seamlessly integrate precision engineering, safety, stability, and durability. Leveraging its unique performance and advantages, ceramic metering pumps find widespread application in the pharmaceutical sector.
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In the entire process of aseptic liquid filling, the metering and filling stage is the only process involving mechanical friction and interaction with sterile liquids. Therefore, ensuring the precision and safety of the metering components is a crucial control factor for minimizing the risks associated with aseptic filling. The performance of ceramic metering pumps directly determines the safety and stability of the customer's product, making it an essential aspect of maintaining quality in aseptic liquid filling processes.
A ceramic metering pump is a device designed to precisely transfer liquids through the precise movement of a plunger, achieving accurate metering. Inside the pump, the plunger undergoes precise reciprocating motion driven by a motor, thereby altering the volume of the pump chamber and facilitating the suction and discharge of the liquid. Due to the ability to precisely control the speed and direction of the plunger's movement through the motor, ceramic metering pumps can achieve highly accurate liquid metering.
1. High PrecisionThe fundamental characteristic of ceramic metering pumps lies in their high precision, as precision is paramount for a metering product. The ceramic pump is required to maintain a metering accuracy error within ±5.
This high precision is manifested in several dimensions:
1Filling accuracy of a single drug under a specific filling condition
2In the context of a single production cycle and specific filling measurement requirements for a certain process, the precision of filling measurements is evaluated in terms of fluctuation accuracy.
3The fluctuation accuracy of measurement precision under different filling measurement requirements within the measurement range.
4Under various viscosity and pH conditions, the measurement fluctuation accuracy of filling precision.
2. Consistency in Product Performance
1In pharmaceutical filling equipment, ceramic metering pumps are not employed as standalone units but rather as part of a larger system comprising 6 to 12, or even more, pump units integrated into a complete filling system. Therefore, the consistency in the product performance of ceramic metering pumps is pivotal, as it directly influences the tunability of manufacturing filling equipment. This consistency ensures that each filling point in the filling system can share a set of control process parameters, facilitating precise metering and filling. The adherence to a uniform set of parameters guarantees the verifiability of the filling equipment, making it an essential characteristic of ceramic metering pumps.
3. Safety of Ceramic Materials
The use of ceramic materials as the core material for pump bodies is due to their excellent structural stability and chemical stability. This choice minimizes the risk of contamination when in direct contact with liquid medications. The ceramic materials selected for ceramic metering pumps are primarily composed of advanced industrial ceramics such as aluminum oxide, zirconium oxide, or other single-crystal structure materials. Typically, the purity of the raw materials exceeds 99.5%, and the manufacturing process, crystal structure, and various performance indicators of the materials are reproducible. These material characteristics ensure that ceramic components manufactured with them exhibit high stability and controllability of risks throughout the product's lifecycle. This is fundamentally different from the ceramics we encounter in our daily lives. Common household or artistic ceramics are typically made from a mixture of silicate materials such as kaolin, quartz, and feldspar, which are fired at high temperatures. Due to the uncertainty of their composition, these ceramics exhibit poor chemical characteristics and process reproducibility. The uniformity and stability of the material's crystal structure cannot be precisely controlled through process design. As a result, ceramic components in these products may experience unverifiable migration of chemical substances, wear resistance issues, and release of insoluble particles during actual usage, aspects that are challenging to validate in the product design phase.
According to the standards outlined in the edition of the Pharmacopoeia of the People's Republic of China, Section Four, page 126: the number of particles equal to or exceeding 10 micrometers per 1ml must not exceed 25, and the number of particles equal to or exceeding 25 micrometers must not exceed 3.
Ceramic metering pumps, starting from the preparation of basic materials, involve a complex manufacturing process with numerous stages. Many factors influence the final performance of the product. The most critical factors can be summarized as follows:
1. Preparation of Ceramic Powders: The ceramic powders used in the manufacturing process require the selection of high-purity aluminum oxide or zirconium oxide. This involves controlling particle size uniformity, press-friendly powder granulation, and other process steps. The prerequisite for manufacturing high-performance ceramic metering pumps is the preparation of ceramic granular powders with outstanding sintering characteristics and controllable particle dispersion.
2. Reproducible Ceramic Blank Manufacturing Process. The process of manufacturing reproducible ceramic blanks involves the compaction and sintering of ceramic powder particles, ultimately yielding raw materials for the production of components in ceramic metering pumps. To ensure the stable performance of subsequent components, the blanks must possess several key characteristics: a dense microstructure, uniform grain size, and consistent mechanical properties.
3. The precision control of key components in ceramic pump manufacturing is crucial. The inherent precision characteristics of ceramic pumps dictate the necessity for ultra-high precision tolerance control in the processing of critical parts such as ceramic plungers and ceramic pump casings. Tolerance clearances must be controlled within 5 micrometers, cylindricality error kept below 0.8 micrometers, roundness error less than 0.6 micrometers, and surface roughness (Ra) maintained at levels below 0.4 micrometers.
4. Design and Verifiability of Ceramic Metering Pump Structure. The structure of the ceramic metering pump should ensure stable accuracy throughout its usage, ease of cleaning and maintenance, and verifiability. The stability of the product's structure is achieved through a precision fit between the pump rod and metal joint, as well as between the ceramic pump sleeve and the metal pump housing, ensuring no relative movement gaps and eliminating the risk of cleaning residue. The inlet and outlet nozzles are seamlessly connected to the metal pump housing, eliminating the risk of liquid medication seepage. This is a crucial factor influencing the accuracy fluctuations and safety risks associated with the use of ceramic metering pumps.
Truking Advanced Materials Technology Co., Ltd. takes GMP standards as the core philosophy for product design and quality management. Centered around validated design, the company engages in the development of ceramic metering pumps. The main aspects of the validation design for ceramic pumps include precision filling validation, physicochemical property validation of materials, consistency validation of ceramic pump structure dimensions, risk validation of migration of material constituents in liquids, validation of insoluble particles in ceramic pumps, and reliability validation of the cleaning process for ceramic pumps.
Truking Advanced Materials Technology Co., Ltd. deeply understands the risk control and usage requirements of pharmaceutical ceramic metering pumps for customers. In collaboration with well-known domestic universities, research institutions, and top-notch aseptic filling technology teams at home and abroad, the company introduces advanced precision ceramic manufacturing technology from Europe. From powder preparation to precision processing and validated design, Truking explores innovative developments in product technology and manufacturing technology for ceramic metering pumps. The goal is to create high-precision, highly reliable, highly verifiable, and low-risk ceramic metering pump products. The company's mission is to provide customers with the most cost-effective ceramic pump-filling solutions.
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