Marya Pharmaceutical Transdermal Drug Delivery Formulation System Provider
Introduction:
The formulation system is a type of pharmaceutical equipment used to mix and dispense liquids, through which adding an API to a solvent such as water for injection, and then formulating it into a pharmaceutical agent that meets the desired concentration after stirring, heating, sterilization and filtration. It is widely used in sterile or non-sterile pharmaceutical field.
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Description of the production steps of a general formulation system:
Classification of the formulation system:
1.General formulation system: It is used for general small molecule chemical preparation, such as aqueous injection, lyophilized powder injection and so on.
2. Complex formulation system: It is used in the production of preparations with complex processes, such as suspensions, emulsions, liposomes, microspheres and other special preparations.
3.Biological formulation system: It is used for the preparation of all kinds of products applying biological engineering technology, such as the semi-finished preparation of antibodies, vaccines, blood products, recombinant proteins and so on, and it can also be used for the production of culture medium, purification buffer and other auxiliary liquid preparation.
4.CIP station system: It is used to assist in the on-line cleaning of tanks and pipelines of various preparation and bioreactor systems, and can be controlled separately or integrated with other systems.
Performance Characteristics of the preparation system:
1.General preparation system
1)The system can be fully automatic, with a modular design, and its follow-up installation and maintenance are convenient.
2)The automatic control system of CIP and SIP can be turned on by one key, automatically detecting the end of cleaning and sterilization, with recipe management, electronic signature, electronic records, audit tracking, and other computer functions.
3)When the equipment is running, it can realize controllable production of key process parameters of drugs (such as temperature, dissolved oxygen, PH, etc.), and can automatically detect them and give an alarm when there are special conditions outside the set parameters, so as to avoid quality problems of drugs.
4)The system follows ASME BPE and GMP design concepts, meets 3D blind corner requirements, and allows for low residue and continuous production. ASME BPEGMP,3D,.
5)Before manufacturing the equipment in our factory, we will carry out a one-to-one three-dimensional design to rationalize the arrangement of pipelines, valves, instruments, etc. in the system to make the operation of the equipment more user-friendly.
2.Complex preparation system
1)We will use ANSYS fluid analysis software to simulate the real situation of the fluid in the tank, and to select suitable agitators and shears based on it, to ensure that the laboratory process can be smoothly transferred to large-scale production.ANSYS,.
2) We will use high-precision oil & water phase transfer pumps to strictly control the mixing ratio of the oil and water phase to ensure the emulsification effect.
3) If there are hazardous raw materials for the production of pharmaceuticals, we will install isolators in the feeding area of the preparation system to ensure the sterility of the API feeding process and personnel protection.
4) The mixing tanks are available in specially shaped designs to achieve very low minimum mixing volumes.,.
5) For suspension products, we will adopt the circulating pipeline design to avoid the uneven composition of the product due to the settling of suspended particles in the pharmaceutical agent caused by long-time filling.
3.Biological preparation system
1)The preparation system communicates with the fermentation system and the purification system, and can automatically deliver the culture medium and purified auxiliary liquid to the specified position, and can be switched flexibly.
2) The steel frame and tanks of the preparation system can be placed in Class C and Class B areas respectively, reducing the risk of contamination due to personnel handling.CB,.
3) We use double valves and valve feedback unit in the key parts of the equipment so that there is no risk of cross-contamination between the cleaning and the material pipeline.
4) The system is equipped with an aseptic collection tank and the liquid filter cartridge can be carried out on-line integrity testing after SIP, in compliance with EU GMP and FDA requirements.
5) The equipment adopts SCADA automatic control system, which can monitor and control the field equipment at any time, and realize data acquisition, equipment control, measurement, parameter adjustment and all kinds of signal alarms, etc. in the central control room.
Details
| We can provide exquisite pharmaceutical grade stainless steel tanks ranging from 2L to 12000L, with internal material of 316L and an electrolytic polishing process Ra<0.4 μ m, which makes it have no hard-to-clean places and can meet the requirements of PED of EU and FDA certification. |
| All the connections to the tanks adopt clamps and NA, and the sealing material is EPDM or PTFE, which complies with the FDA. The jacket nozzle connection adopts Union or flange, and the sealing gasket is made of PTFE. |
| Each tank is equipped with a set of safety devices including a burst disc or safety valve and a site pressure indicator to assure the safety of equipment and personnel to the largest extent. |
| The weighing or liquid level detecting system is used for water addition and material feeding control. |
| Before the WFI (water for injection) enters the preparation tank, we can use a clean-grade sterile double tube plate heat exchanger to cool it to the set temperature, which can also be used in integrity testing of the liquid filter element. |
| The temperature control and display of the product are realized by the temperature probe installed at the bottom of the tank, and the pressure control and display of the tank are realized by the pressure probe installed at the top of the tank. |
| To fully mix the product and speed heat transmitting, we install a magnetic stirrer driven by electromagnetic coupling with frequency conversion speed regulation at the bottom of the tank or install a mechanical stirrer with frequency conversion at the top of the tank. |
| All the sterile tanks are equipped with spray ball to complete CIP. |
| Sterile ventilation and air exhaust filters are installed on the top of every tank, to assure that all operations are under sterile conditions. |
The tanks are all equipped with sight glasses with illumination to monitor and control the level.
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| We use a sterilization-grade liquid filter made of polyethersulfone (PES), which can withstand pH 1-14 solutions and temperatures up to 150ºC, and has good resistance to organic solvents. It has excellent filtration performance and reliable bacterial retention ability, fully meeting the filtration requirements of pharmaceutical processes. |
Product Parameters
| Name |
Parameters |
| Working volume |
2~15000L |
| Stirring speed control accuracy |
Speed range 0~450rpm
±3.0% |
| Temperature control accuracy |
Temperature range-10~150ºC
±0.2ºC |
| Pressure control accuracy |
Pressure range-0.01Mpa~0.06Mpa
±0.01MPa |
| Weighing control accuracy |
3‰ |
| Power supply |
380V 50Hz
(Note: Other voltages require a transformer) |
| Sealing and protection levels |
IP65 |
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