Centrifuges are widely used in pharmaceutical industry, how should pharmaceutical companies choose rationally?

　　Pharmaceutical Network Technical Article: Centrifuges, as solid and liquid phase separation equipment, is one of the main production equipment of pharmaceutical manufacturers, widely used in the pharmaceutical industry For example, in biopharmaceuticals, cells (bacteria), proteins, enzymes, DNA, peptides, etc are usually isolated from the fermentation solution, which requires the action of centrifugal force through high-speed rotation of centrifuges;
Centrifuges play an important role in pharmaceutical production, but the pharmaceutical industry needs to produce in accordance with the GMP requirements of the "Pharmaceutical Production Quality Management Practices", which also include requirements for pharmaceutical machinery, equipment and instruments Therefore, centrifuges in the design, selection, installation and other aspects should also need to strictly comply with the requirements of drug production
"In pharmaceutical production, the selection of suitable, easy to clean, disinfection, easy to operate, can prevent errors, reduce pollution and other centrifuges are more popular in the market "There are industry sources who say, " said one industry source The author was informed that, in order to better promote the development of centrifuge technology in China, so that centrifuges in the pharmaceutical industry to play an increasingly important role in recent years, China's centrifuge production enterprises continue to forge ahead, centrifuge technology has made rapid progress
But in the actual production process, how should the pharmaceutical factory choose the centrifuge correctly, its parameters, rotors and so on how to grasp? How can a pharmaceutical company choose the right sterilization method and what can be done to make centrifugal effect better? In order to better promote the wide application of centrifuges in the pharmaceutical industry, promote the development of the pharmaceutical industry for the benefit of the people, recently, as a centrifuge manufacturer, Shanghai Lu Xiangyi shared their experience in the centrifuge profession
First, how to correctly select the main parameters of centrifuges Centrifuges are indispensable equipment in biopharmaceuticals, then how to correctly select centrifuges? Shanghai Lu Xiangyi related technical personnel suggested that the choice of centrifuges should pay attention to the following points: 1, the choice of the maximum relative centrifugal force pharmaceutical plant according to different process requirements to choose the maximum relative centrifugal force required for separation, the manufacturer will be the maximum relative centrifugal force of the centrifuge marked in the specification or publicity materials, the maximum relative centrifugal force with RCF, also known as separation factor, in the centrifugation process to play a leading role When selecting the model, the drug factory sometimes only pay attention to the speed and ignore the separation factor, this is a mistake, because the separation factor and the speed of the square and rotation radius are both related, as shown in the following formula: RCF: maximum relative centrifugal force is expressed by x g as a multiple of gravity acceleration;
Example situ to calculate RCF: Shanghai Luxiang instrument centrifuge figure 1 2, the choice of speed selected RCF can correspond to the choice of centrifuge rotor speed
3, capacity selection can meet the RCF and speed of the corresponding capacity, these parameters manufacturers will be provided in the website, color page or instruction manual, centrifuges can choose with a number of different capacity rotors, pharmaceutical companies can be screened according to demand At the same time to meet the above 3 points to meet the use of pharmaceutical factory requirements
4 The choice of refrigeration or non-refrigeration centrifuges Pharmaceutical companies often ask: I do not need refrigeration why choose refrigeration centrifuges? This is because the rotor in high-speed rotation and air friction in the pot cavity and produce a lot of heat, and the motor in high-speed operation will also have heat generation, if you do not choose refrigeration centrifuges, centrifuges run after the temperature of the pot rose very quickly, high up to 80 degrees, will affect the activity of the required active ingredients in the material, but also affect the service life of centrifuges, so pharmaceutical centrifuges choose to select refrigeration centrifuges
Second, how to choose the correct rotor rotor is an important component of the centrifuge, the types of rotors include corner rotors, horizontal rotors and continuous rotors Angle rotor centrifugal radius is high speed, capacity is relatively small horizontal rotor, suitable for the separation of small particles extraction; horizontal rotor is suitable for the separation extraction of large particles, relative to the angle rotor low speed, but the capacity is relatively large;
Example 1: Separation protein selection high-speed frozen centrifuge rotor: angle rotor RCF s 14400 x g speed s 9000 rpm capacity s 500ml x 6 case 2: large-capacity frozen centrifuge rotor selected when extracting enzymes in animal internal organs: horizontal turn Sub-RCF-6260 x g-speed s 4000 rpm capacity s 2000ml x 6 case3: High-speed frozen centrifuge rotor: continuous flower RCF s 28100 x g Speed: 16000 rpm Capacity: 2000ml x 6 cases 4: centrifugal E coli select high-speed frozen centrifuge rotor: angle rotor RCF s 11600 x g speed s 7000 rpm capacity s 10 000ml x 6 three, how to correctly choose sterilization methods: biopharmaceuticals, especially vaccine production on the process hygiene requirements are very strict, especially GMP certification requirements are very high, centrifuges and materials contact in addition to continuous flow centrifuge rotors, other contact with centrifuges, other are in contact with centrifuges, In autoclave to choose the wet heat sterilization method, the temperature is 121 degrees, must open the lid of the centrifuge bottle sterilization, if the lid is covered sterilization, centrifugal bottle (material PP/PE/PC) in high temperature and high pressure will produce gas and deformation can not be used
Four, how can the drug factory to make centrifugal effect good centrifuge purchase, manufacturers will be door-to-door, and training operators, this time some pharmaceutical companies have not really need to choose the appropriate centrifugal material, but the equipment in place simple debugging, wait until the batch to be centrifuged first read the instructions, deepen the impression, choose the correct centrifugal force and corresponding speed, choose centrifugal time, according to the pharmaceutical plant's process selection, time is too long efficiency, time is too short separation effect, so according to the actual material separation effect Set the temperature, in no special provisions of the pharmaceutical company usually choose 4 degrees, set the lift speed gear, in the centrifuge security will generally choose to rise 4, down 5 is more appropriate, but some special pharmaceutical needs to slow down time to adjust to the slowest gear, there are requirements in the procedure special design of a despeed Curves, this needs to be proposed at the time of purchase, such as the calf's serum separation, if the normal de-speed then in the final brake force reaction, will have been isolated plasma and red blood cells turbid, this need to design a set of slow-slow centrifuge procedures, so that the separation of the effect is better
Fifth, how to prepare the technical requirements of the URS file in the pharmaceutical factory is the pharmaceutical factory to standardize the procurement needs of the document, content more including business, technology and other content, corresponding to the main technical part of the centrifuge includes the following and writing format: 1) the maximum relative centrifugal force should not be less than xxxx?g
2) Single centrifugal capacity of xxxx L
3) Can effectively maintain the centrifugal cavity temperature in xx-xx degrees C, temperature fluctuations should be less than xx degrees C, open refrigeration for half an hour, can reach xx-xx degrees C
4) The installation, commissioning, operation and maintenance of the machine are in line with environmental requirements, and the running noise is xx dB(A)
5) The centrifuge has the chain control function of opening the door cover and operating state of the equipment, so as to ensure that the centrifuge door cover cannot be opened during the operation of the equipment
6) The equipment has an emergency stop control switch, the switch should be located in the easy-to-touch position
7) Should be equipped with over-temperature protection, overspeed protection, door cover protection, unbalanced protection and other alarm devices
8) Centrifugal cup material should be wear-resistant, resistant to high temperature sterilization, resistance to commonly used solvents and other properties
9) The parametersetting and operation of the device should be controlled by the display, the speed setting or centrifugal force setting can be carried out, the display is the Chinese interface, should be able to display the centrifugal speed, centrifugal force, temperature, running time and other parameters
10) Each electrical line should have a label, and the location is obvious, electrical control components should have a complete product nameplate and logo, in order to facilitate maintenance and maintenance
11) Provide a list of spare parts and prices for spare parts within three years
6 The use of centrifuges safety centrifuges operating at high speed, even small errors in operation may cause serious damage to centrifuges, to understand safety and precautions and correct operation, to avoid damage to operators and the use of centrifuge performance affected
1) The inspection work before the start of the experiment includes: whether the rotor and other accessories are normal, whether the rotor is properly placed on the spindle, whether the center nut or pressure head on the rotor body is loose, whether the centrifuge/centrifuge tube is deformed or cracked
2) Centrifugal bottle / centrifugal tube on the balance of the weighing flat, adjust the amount of centrifugal material, so that the weight of the centrifugal bottle / centrifugal tube containing centrifugal material as far as possible, do not exceed the maximum amount of allowed imbalance, generally 2 grams, the centrifugal bottle / centrifugal tube symmetrically placed in the rotor
3) Before starting the centrifuge, make sure that the centrifuge has been cleaned and free of debris
4) When the machine is running, do not open the centrifuge door cover, not to move the centrifuge, the door cover can not put any thing, to prevent the door cover automatically open when the damage to the door cover items
5) After centrifugation, the speed slowly drops, and so the rotor completely stops turning, can press the stop key to open the cap, open the centrifuge door cap to remove the centrifuge bottle / centrifugal tube, take out the centrifuge / centrifugal tube should be careful, do not make the precipitated material because of vibration and movement rise, cloudy
6) When using centrifuges, if the screen failure alarm during operation, should immediately stop or cut off the power supply, if the centrifuge vibration is large, there is an imbalance in the table instrument, if the device is found to have a centrifuge / centrifugal tube broken sound, should immediately stop using and check, before using it again, be sure to clean up the debris
7) Pay attention to clean after use and cut off the power supply
Seven, centrifuge maintenance 1) after each use of the instrument, first take out the rotor, and then use cotton cloth for the centrifugal cavity to clean, dry After the rotor is removed from the centrifuge cavity, it should be cleaned with neutral washing liquid in time, dried with a dry cotton cloth, and stored in a dry and ventilated place, not allowed to scrub the rotor with a non-neutral cleaning agent to prevent chemical corrosion
2) Centrifuge for a long time not to use, to clean the centrifugal inner cavity, in the centrifuge room into the desiccant to absorb moisture, to prevent rusting of the drive shaft, on the motor shaft coated with a little grease protection
3) The surface of the control panel must be kept clean, the control panel can only be cleaned with a dry soft cloth and cannot touch water, preventing water from entering the control circuit board and burning the control circuit board
4) Do not touch, damage the drive shaft cone, before the rotor is loaded, use a soft cloth to the drive shaft and rotor cone hole to wipe clean, and coatad with a little medical Vaseline or other grease
5) Rotors, centrifugal test bottles or hanging cups and other tools can not be placed on the centrifuge door cover, the head, in order to prevent scratches, damage The door cover and the outer surface of the chassis can only be wiped with a soft cloth and a neutral cleaning agent to prevent the paint layer from falling off The use of aggressive disinfectants (e.g 84 disinfectants) for sterilizing centrifuges is prohibited
The above is Shanghai Lu Xiangyi and pharmaceutical manufacturers in the process of communication some experience, for your reference.