I. Material selection

Direct contact with the drug materials, the need to identify the physical and chemical properties of the material to ensure that it does not react with the drug, adsorption or release and other adverse effects, and according to the product process characteristics to consider temperature resistance, corrosion resistance, wear resistance, strength and other characteristics of the appropriate choice to avoid blind selection can not meet the process requirements or produce waste.

Metal materials are currently used in the pharmaceutical industry, stainless steel materials, ISPE minimum requirements for stainless steel AISI 300 or more, in contact with the drug at the domestic pharmaceutical enterprises currently use ultra-low carbon austenitic stainless steel 316L, do not contact the important parts of the drug selection of 304 stainless steel. It should be noted that ultra-low carbon stainless steel is prone to carburization reaction, 316L should not be installed around the iron-carbon spill material.

Non-metallic materials mostly use polytetrafluoroethylene, polyvinylidene fluoride, polypropylene, etc. Rubber sealing materials mostly use natural rubber, silicone rubber and other materials with more stable chemical properties.

II. the process requirements

Equipment selection first to meet the process, the process parameters requirements, and based on these requirements to select the corresponding function of the equipment is particularly important.

The maximum production capacity of the equipment should be greater than the design process requirements, and try to avoid long-term operation of the equipment under the maximum capacity load.

The highest working accuracy of the equipment should be higher than the process accuracy requirements, leaving an adjustment margin for the product quality parameters.

III. the choice of equipment structure

Pharmaceutical equipment mechanical transmission structure should be as simple as possible, the transmission mechanism should be used linkage mechanism, pneumatic mechanism, standard parts transmission mechanism, etc..

The design of the equipment structure should be easy to operate, for example: the operator's activity distance is the shortest, the activity space is appropriate, it is not easy to operate the error, reasonable ergonomic design to avoid errors occurring in personnel fatigue, the operating interface as far as possible using familiar language to avoid misoperation, for the operation of key parameters have tips and reconfirmation steps, the important alarm affecting the process parameters should be used Sound and light alarm.

The structure of the equipment should be considered to facilitate maintenance, for example: the use of reliable design, sufficient maintenance space to disassemble parts, fragile parts should be easy to disassemble, there is a logical relationship between the zero position of the drive system is clearly marked, as far as possible, the use of fault alarm system to display important fault information, all wires and terminals with reliable connection and labeling, power distribution boxes have the function of locking and tagging.

The surface of the equipment to be cleaned should usually be smooth, the experimental proof of surface roughness Ra0.4 than Ra08 flushing effect is 2.5 times higher, the surface in contact with about products need to be rounded transition, flat, smooth, no dead ends, easy to clean, while considering the feasibility of processing, the surface of parts not in contact with drugs should also be flat, smooth, easy to clean.

IV. the detection function

Equipment selection is recommended to consider the online detection function, which is especially important for online monitoring of key process parameters during mass production.

The selection of scales, gauges, instruments and meters should consider using metric units of measurement as far as possible, and be able to clearly identify the units of measurement. The measurement range, accuracy and resolution can meet the process requirements and should not be defined by the highest accuracy of the measurement equipment as the process demand accuracy.

Usually online detection sensors need to consider corrosion resistance, temperature resistance, stability, calibratable performance, no reaction with drugs, adsorption, release, etc. The surface of the parts in contact with the drug is smooth and flat, and personal safety factors need to be considered, such as: reliable connection, no excessive ionizing radiation, etc.

Key process parameters testing results should preferably have data records and trend graphs for easy analysis and tracking.

In the parts prone to deviations installed with appropriate detection and control devices, with sound and light alarm, automatic rejection or automatic feedback correction function.

V. Safety, environmental protection and health requirements

Equipment selection needs to consider the local government's regulatory requirements for safety and environment.

Special hazardous equipment should be selected from suppliers with design, manufacturing and installation qualifications.

Special hazardous equipment and pipelines should have safety pressure relief device, anti-corrosion and anti-leakage device, explosion-proof and anti-static device, difficult communication device and emergency fault cut-off function.

The discharged process wastewater and process waste gas need to be properly treated so that they meet the requirements of environmental protection specifications.

The equipment needs to consider personal and product safety. There are usually designs for overload protection, photoelectric induction shutdown protection for entering dangerous parts, safety alarm devices, ionizing radiation protection, noise, illumination, etc.

Equipment to consider ergonomic design, reduce labor intensity and long-term high-frequency activity injury.

Especially for the generation of dust, flammable volatile aerosol equipment, the environment needs to fully consider the design of explosion-proof, anti-static devices.

VI. the requirements of the project

The power energy (water, electricity, gas, etc.) and waste water and gas emissions provided for the equipment should be matched, and designed, constructed and accepted at the same time as the equipment.

Production equipment and plant facilities, power and equipment as well as the use of management have mutual influence and interface problems, requiring equipment interfaces and process linkage equipment to be standardized, in the engineering design to deal with the interface relationship.

VII. automatic control system

Pharmaceutical equipment should be used to PLC (programmable logical control, PLC) of the automatic control system, because of its high stability, confidentiality, convenience, control ability, calculation ability, automatic detection ability, operability and other advantages.

Equipment self-control system should be programmed in accordance with the process requirements and user needs before drafting detailed self-control system action detailed description of the document, and get the user's review and approval to ensure that the self-control system meets the user's needs and to provide a checkable basis for verification.

VIII. cleaning equipment

Recommend the choice of in-situ automatic cleaning equipment, systems, preferably installed with online cleaning detection devices to ensure that the cleaning system to achieve the purpose of washing.

Washing area of special cleaning equipment, drying equipment is recommended to be designed to be cleaned into the mouth and exit partition set. Avoid the backflow of cleaned materials to produce pollution.

Cleaning equipment should consider the design of self-cleaning function to ensure that the equipment itself does not produce pollution to the cleaned materials.

The drainage mouth of cleaning equipment should not produce sewage backflow and turbidity gas backflow, usually consider designing with backwater bend, one-way valve, cut off and closed drainage pipe device.