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Pharmaceutical Formulation System

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 the sterile or non-sterile pharmaceutical field.

Core Advantages
Core Technology
Technical Parameters
Application Scenarios
Optional Systems

1. Classification:

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 various products of 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 preparation of culture medium production, purified buffer solution and other auxiliary liquid.

2. Advantages:

1）Modular design, cost-saving and worry-free
The pre-tested modular equipment provides significant savings on installation, faster delivery, and a high level of flexibility and convenience.

2）Fully automatic running system, intelligent and efficient
The one-button automatic control system of CIP and SIP can automatically detect the end of cleaning and sterilization, with recipe management, electronic signature, electronic records, audit tracking and other computer functions, realizing production automation.

3）Controllable production with key process parameters and visualized monitoring of the production process
When the equipment is running, it can realize controllable production of drugs with key process parameters such as temperature, dissolved oxygen, PH, etc., and automatically detect them and give an alarm when there are special circumstances outside of the set parameters, so as to avoid quality problems of drugs.

4.） 3D simulation design and rational layout
1. Before manufacturing the equipment in our factory, we will carry out the same size ratio 3D design to rationalize the arrangement of pipelines, valves, instruments, etc. in the system to make the operation of the equipment more user-friendly.

3.Design details：
1) 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.

2) All the connections to the tanks adopt clamps and NA, and the sealing material is EPDM or PTFE, which is in compliance with FDA. Jacket nozzle connection adopts Union or flange, and the sealing gasket is made of PTFE.

3) Each tank is equipped with a set of safety device including a burst disc or safety valve and a site pressure indicator to assure the safety of equipment and personnel to the largest extent.

4) The weighing or liquid level detecting system is used for water addition and material feeding control.

5) Before the WFI (water for injection) enters the preparation tank, we can use a clean grade sterile double tube plate heat ex-changer to cool it to the set temperature, which can also be used in integrity testing of the liquid filter element.

6) The temperature control and display of the product is realized by the temperature probe installed at the bottom of the tank, and the pressure control and display of the tank is realized by the pressure probe installed at the top of the tank.

7) 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.

8) All the sterile tanks are equipped with spray ball to complete CIP.

9) Sterile ventilation and air exhaust filters are installed on the top of every tank, to assure that all operations are under the sterile conditions.

10) The tanks are all equipped with sight glasses with illumination to monitor and control the level.

11) We use a sterilization grade liquid filter which is made of polyethersulfone (PES), can withstand solutions of pH 1-14 and temperatures up to 150℃, 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.

4.Design parameters：

Name	Parameters
Volume	2~15000L
Material	304、316L、904L、TA2
Stirring type	Upper mechanical stirring, lower magnetic stirring
Stirring speed control accuracy	Speed range 0~450rpm ±3.0%
Temperature control accuracy	Temperature range-10~150℃ ±0.2℃
Pressure control accuracy	Pressure range-0.01Mpa~0.06Mpa ±0.01MPa
Weighing control accuracy	3‰
Power supply	380V 50Hz （Note：Other voltages require transformer）
IP grade	IP65

Why MARYA

Trusted Worldwide

20 +

Years rich Industry Experience

3 +

Production Bases

60 +

Successful Projects in 60 Countries

300 +

Loyal Clientele

Company Honors and Certificates

CE Bottle unscrambler and labeling machine

Some of Our Customers

Well - known visiting Clients

Invited to the Embassy of the United Republic of Tanzania in Guangzhou to discuss projects

Tanzanian Vice President Visits Marya Pharmaceutical EPC Project

NBA (Zimbabwe National Biotechnology Authority) conducts FAT at MARYA’s Factory

NOVO NORDISK client Visit

Clients visit the factory's liquid preparation system

Argentine client visits for FAT in MARYA

Successful Cases

Zimbabwe Vial Filling Line

Malaysia Prefilled Syringe Filling line

Argentina Vial and Ampoule line

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Services

Full-process Consulting Services

Whether you are preparing to build a new pharmaceutical factory, build a cleanroom that complies with local GMP regulations, or purchase pharmaceutical equipment to develop a new production line, whether it is a separate cleanroom or pharmaceutical machine project, or a one-stop solution, Marya's professional teams in the fields of pharmaceutical technical process, process equipment, decoration engineering, HVAC engineering, pipeline engineering, utility equipment, intelligent automatic control systems, project cost and other fields can provide you with full-process technical consulting services, and solve your needs one-on-one.

2D/3D Design Modeling Services

Marya project design team is composed of professional CAD and BIM engineers with more than 20 years of comprehensive industry experience and can provide you with comprehensive design services, including but not limited to process layout drawings, technical process charts, 3D models and animations, air conditioning system scheme design, construction drawing design, plant/pharmaceutical machine layout drawings, etc.

Machine Customization Services

Based on the individual needs of clients in different countries, Marya helps you clarify specific needs, match appropriate models, and customize one stop filling solutions for sterile small-volume preparations, large-volume injections, oral liquids/syrups, solid preparations, etc.

Validation Services (FAT/SAT)

Marya will appoint an engineer with rich project management experience as the person in charge, who will be fully responsible for project management and liaison work. After the equipment is manufactured, our engineers and the buyer's representatives will participate in the FAT test. After the equipment arrives at the buyer's site, it will be installed and debugged. After the equipment reaches optimal operation, the buyer will conduct SAT testing and inspection.

Customer FAQ

Are you manufacturer or trader? Where are your factory located?

We are manufacturer. Our factory is located in Changsha and Suzhou.

What certificate do you have?

We have CE, ISO, ROHS, SGS etc.

What documents will you provide?

Usually we will provide DQ, IQ, PQ, OQ, FAT, SAT, operation manual, maintenance instruction,layout drawing.etc.

What is the production lead time?

Standard 25-60 days after deposit received and technical data confirmed, we can make special arrangement for better shipment if needed;
Standard 60-150 days after deposit received and technical data confirmed based on different machines, we can make special arrangement for better shipment if needed.

How long is your warranty? Can we extend?

12 months after installation and commissioning or 18 moths from the day that the equipment arrived on site. Prevail in the first arrival date.
Warranty can be extended with extra charge.

Have you done similar projects overseas?

Marya’s business map covers more than 60 countries and regions around the world, such as the United States, Russia, Bulgaria, Britain, Portugal, Poland, Switzerland, ltaly, New Zealand, Malta, Moldova, Malaysia, Uzbekistan, lran, Egypt, Saudi Arabia, UAE, Ecuador, Dominica, Panama, Uruguay, Argentina, Tanzania, Zimbabwe, Ethiopia, Indonesia, Bangladesh, and others, and we gained good reputation.

Key words:

Formulation system

Preparation system

Pharmaceutical Liquid Preparation system

Formulation Mixing Tank system

Nasal Spray Filling and Capping Machine

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