In order to eliminate the risk of cross contamination during production and reduce the probability of microbiological contamination in the key manufacturing process of pharmaceutical, biotechnological and fine chemistry industries, the process production standard must be met design of each detail must meet high quality requirements, and relevant national and international mandatory standards must be complied with.
Modular process unit design is the most efficient way to achieve quick response and cut down costs. High-performance modular process unit design can ensure the barrier free and stable operation of production.
Being your reliable partner; Tianfu Enterprise has many years of experience and perfect technology to provide complete modularity solution in the production system. We are capable of providing process module system for following products in the pharmaceutical field:
Freeze-drying or hydro-acupuncture/oil needle liquid preparation system:
·Large transfusion liquid preparation system
·Traditional Chinese medicine injection liquid preparation system
·Oral liquid preparation system
·Eye drops liquid preparation system
·Small volume pilot test automatic liquid preparation system
Single tank mobile CIP system
•CIP Double tank or multi tank fixed CIP system
The process design of the whole process module, detailed piping and automation process will be completed by experienced staff under the leadership of the project manager who is familiar with your needs and expectations. Renderings and technical specifications will be delivered to you on time.
We completed the modular project according to the following process:
• Conceptual design and detailed design
• Procurement, manufacturing, assembly
• Installation and validation (factory)
• Field installation
• IQ/OQ and test run
• Service and support
• Case summary
The technological design of the entire process module, detailed pipeline and automatic process will be done by experienced staff according to your requirements and under the guidance of project manager. Design sketches and technical parameters will be given to you in time.
We complete the modular project according to following procedures:
·Concept design and detailed design
·Procurement, manufacturing and assembly
·Installation and verification (done In the factory)
·Field installation
·IQ/OQ and test run
·Service and support
·Case summary
The process team of Tianfu Enterprise uses the most up to date CAD technique to design equal proportion welding drawing, three-dimensional cant drawing and working drawing. We are able to expand to three dimensional diagrams in order to offer a visual technological design. Automated design will be done by knowledgeable automation engineer hand in hand with process engineer, and it shall completely comply with the requirements of CGMP. Tianfu Enterprise process automation system is designed according to and in compliance with the provisions of 21CFR PART11, ISAS-88. and other applicable technical requirements of customers.
Processing and testing: Tianfu Enterprise possesses modern equipment and professional experience in the R&D of production technology and testing, therefore the system delivered by us can meet FDA, CGMP and ASME-BPE standards. Our professional teams, including our well-trained professional welding technicians, mechanical engineers, electrical engineers, all take pride in the high quality products made by them.
Test of work acceptance is done in fully equipped FAT field.
Tianfu Enterprise can provide installation and debug support, which are done by the engineers of various specialties who have been kept busy during process design and the entire processing period. The goal and method of verification is decided by users in advance and will be achieved by making a "verification management plan" table. The "verification management plan" contains process flow/in place cleaning statement, testing method, verification standard and other necessary documents. Among all the options, Tianfu Enterprise can choose to write IQ/OQ files for the implementation of verification in order to meet the requirements of specifications at home and abroad and provide remote diagnosis support.
Our Advantage
20+ Years Experience
Our products are sold all over Europe,North&South America,Sino-East,Asia and pacific area as well as Africa,we establish long term.
Quality service
Company cooperates with research institutes.We strictly control the process of raw materials up to finished product.
24 hour service
Quick and clear response to customers questions. Warm after sale service, we will help to solve the problems in your usage.
High quality
Dedicated to serving customers first,we provide reasonable prices, high quality products.
FAQ
1. What kinds of payment terms can you accept?
The most commonly used payment terms are T/T,L/C,Paypal,Western union, etc.
2. What's your delivery time?
Usually we will arrange the shipment within 15-45days after confirming the order.
3. How about the packing?
Standard packing,we also accept customized pack.
4.What is the Min Order Quantity?
Different products have different MOQ.
5.How about the validity of quotation?
In normal,the validity can keep a month,but when market changes fast,the validity will be short accordingly.
6.What documents you provide?
Usually,we provide Commerical Invoice, Packing List,Bill of loading,COA,and Origin of certificate.If your markets have any special requirements,let us know.
For more information,please don't hesitate to contact me.