User:Ashishtigga/sandbox

STANDARD OPERATING  PROCEDURES

A standard operating procedure is step to step compilation of the instructions by an organisation to carry out complex routine operations. SOPs aim to achieve efficiency, quality, uniform performance and desired output.

SOPs are written by step-by-step procedures that quality control,quality assurance, and production units use in order to assure the accuracy and precision of the quantitative experimental results and materials that they generate and provide in support of other units such as Research and Development, manufacturing and production. These SOPs are useful in carrying out various instruments which would lead to yield and constant quality of product for example in case of a bio-reacter or fermenter.

FERMENTERS -

BASIC FUNCTION OF FERMENTER-The main function of a fermenter is to provide a controlled environment for growth of a microorganism, or a defined mixture of microorganism, to obtain a desired product while bioreactors refer to production units of mammalian and plant cell culture. Fermenters are made up in such a form to qualify certain criterea like should be durable and should operate for desired number of period.

There are following necessary requirements for this purpose:

(a) The agitator (impeller) for mixing

(b) Stirrer glands and bearings meant for aseptic sealing

(c) Baffles for checking the vortex resulting into foaming

(d) The sparger (aeration) meant for introducing air into the liquid.

BIOREACTER-

A bioreactor refers to any manufactured device or system that supports a biologically active environment. In one case, a bioreactor is a vessel in which a various chemical process is carried out which involves organisms. This process can either be anaerobic or aerobic. These bioreactors are commonly cylindrical, ranging in size from litres to cubic metres, and are often made of stainless steel.On the basis of mode of operation, a bioreactor may be classified as batch,fed batch or continuous.

Differences between Fermenter and bioreacter is in case of Bioreacter any kind of biochemical reaction can take place where as in case of fermenter only fermentation can take place.Metabolites like pharmaceuticals,drugs,amino acids are used in bioreacter where as in case of fermenters only alcohol and acids are used. Bioreacter can operate under both aerobic and anaerobic conditions where as in case of fermenters only anaerobic condition is required.

Various processes and production is carried out which require specific manual based procedure to carry out proper yeild and production. These steps are needed to be followed for getting proper yield and output. Few examples are stated below to carry out certain processes guided by terms of Bio-processing and usage of instruments which include manuals to be operated.

EXAMPLE- STANDARD OPERATING PROCEDURE OF A LABORATORY BASED MINI-BIOREACTER

1.PURPOSE- The purpose of this SOP is specific procedure for carrying out and create a bench scale for a bioreacter and execute a form of bioprocessing: microbial fermentation of yeast.

2.SCOPE-This procedure describes the method to grow yeast.

3.MATERIALS AND EQUIPMENT-

MATERIALS- known quantity of bakers yeast(2.1g),Sugar in Raw(Using                       nutritional value chart),Soy flour,100ml water.

EQUIPMENT- 250 mL Shake Flask,Thermometer,One-Hole Stopper,Tubing (silicone and polypropylene),100 mL graduated cylinder,1000 mL beaker	Timer,Microwave or hot plate (centrally located),Scale(centerally located).

3.PROCEDURES-

4.1 Weigh the yeast powder by use of scale.

4.2 Weigh the sugar by use of scale.

4.3 Weigh the flour by use of scale.

4.4 Fill the shake flask with 100mL of water using the graduated cylinder.

4.5 Placed flask with measured water in microwave for 20 seconds at high. If temperature is above 115° F, Don’t proceed until temperature drops to at least 115° F and then proceed.

4.6 Add materials, one at a time, to the shaker flask with warm water. Swirl flask

BIOREACTER SET UP-

4.7	Completely fill 100 ml with water in graduated cylinder.

4.8	Place a 1000 mL beaker, upside down, on top of cylinder(graduated)with water.Supporting thebeaker with one hand and the cylinder with the other, flip the equipment over so the cylinder is now upside down in the beaker. Be careful to keep as much water in the cylinder as possible.

4.9	Fill the beaker with 500 mL of water.

4.10 Position the curved end of the silicone tubing in the bottom of the graduated cylinder. You can lift the cylinder slightly in order to do this. Once the tubing is in place, secure the cylinder in place by taping it to the side of the beaker, making sure it is as straight as possible. Position the cylinder so the numbers can be easily read.

4.11 Push the rubber stopper into the top of the shaker flask.

4.12 On the Data Log sheet, record the starting volume in the graduated cylinder. Every minute for 15 minutes, record the measurement in the graduated cylinder.

STANDARD OPERATING PROCEDURE FERMENTER

1. Check the panel switch board which is connected to power supply. 2. Check cable which is RPM connected to the motor. 3. Check all the cables such as ph, dissolved oxygen and Temperature sensor which are connected to the vessel. 4. Power ON the switch board. 5. Plug on the power switch. 6. Now, panel is ON and PLC will display “Account Type” & “Password” on the screen. The screen will be like this: Enter the account type & password correctly. 7. At this step user can access all the functions for fermentation process. 8. In the fermentation process user can follow the following steps:

STEP 1-MAIN MENU

Main menu will consist of four controls known as fermentation menu process.As per user choice any menu can be access and changes can be made.Menu consists of option to start and control fermentation process.Before switching ON make sure to check all inputs and individual controls. To check or control individual parameter its individual CTRL should be switched ON along with fermenter CTRL.

A) Temperature control: Use this option to set the temperature that has to be achieved or maintained during fermentation. For temperature setting, temperature control should be at OFF state. By touching the button against Temperature SV, desired value of temperature is entered. For temperature activation, fermentation control and individual should be ON. If Temp MV > Temp SV, Cooling is Activated. If Temp SV > Temp MV, Heating is Activated. Dead Band (DB): The user can set this parameter in the range from 0 to 99.9. In DB range, the heating and cooling controls will be OFF.

B) pH Control: This option allows the user to achieve the required pH & maintain it throughout of the batch. This control is activated if fermentation & individual controls are BOTH ‘ON’.

When button in front of pH SV & DB (Dead band) is pressed, a keypad entry will automatically displayed and desired Set Value is entered. If pH MV>pH SV, Acid Indicator will be activated. If pH SV>pH MV, Base indicator will be activated. pH is controlled by Acid & Base peristaltic pumps automatically. It can be runned manually to.

C) Agitation Control: This menu is used to control the mixing rate or RPM of the Fermenter. This control is activated if fermentation & individual controls are BOTH “ON”. For agitation setting, fermentation and individual control should be at OFF state. Similarly when button in front of Agitation is pressed, a keypad entry will automatically display and desired set value is entered. [RPM range: 50-1000].

Air Flow: User switches ON the control of Air & adjust the air flow through the rota meter. This process also in manual mode through the switch. D) Antifoam Control: Operation of the anti-foam (AF) pump can be controlled using this option. This control is activated if fermentation & individual control are BOTH ‘ON’. The foam control works properly only if the AF pump is carefully calibrated before each batch. E) Feed control: This option can be used to set the flow rate of the feed pump. This control is activated if fermentation & individual controls are BOTH “ON”. Feed control works properly only if the feed pump is carefully calibrated before each batch. By touching the buttons against ON time and OFF time, feed ON and OFF time is entered by keypad entry. F) DO control: Feed the set value of DO and RPM as per protocol. User can also set the control setting of PRM using function Control setting.

STEP 2- PROCESS AT GLANCE The screen displays the overall status of the fermentation process which was conducted and various parameters involved.

STEP 3- DATA LOGGING

It displays the values of each parameter on the computer through the software provide by company.

End the process by switching off the power switch of panel and main board

REFRENCES