SOP for Sterility Using Streitest Equinox

1.0 PURPOSE

To lay down the procedure for Sterility using Steritest Equinox

2.0 SCOPE

It is applicable to Microbiology Laboratory

3.0 RESPONSIBILITY

Microbiologist

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Recipe preparation for Streitest Equinox

5.1.1 Double-click on the icon displayed on the desktop.
5.1.2 Access to the software is password protected. When the software opens the password window is displayed
5.1.3 Enter the password then click on OK to confirm the entry. The default password is Millipore
5.1.4 The main screen of the software is displayed.
5.1.5 To quit the software select the exit command in the file menu.
5.1.6 The screen is divided into four areas
5.1.7 The work file column in which a list of the product recipe contained in the work file is displayed.
5.1.8 The Steritest Equinox pump column in which the list of product recipe loaded into the connected Steritest Equinox pump is displayed.
5.1.9 The Product recipe properties flied in which the title and comment of the selected Product recipe displayed.
5.1.10 The list of the handling steps making up the selected product recipe with, for each step, its order number, its type, the programmed pump speed and timer setting and a comment
5.1.11 The product recipe are stored in the alphabetical order over all the product recipe contained in the work file and loaded into the steritest equinox pump.
5.1.12 At the top of the screen there is a menu bar (file, product recipe, steritest, utilities )
The menus provide access to the basic functions of the application.

5.2 File menu

5.2.1 When you click on the file menu the following commands appear

File	SOP	Steritest	Utilities
Save
Print….
Exit

5.2.2 These commands enable the following actions
5.2.3 Save the work file
5.2.4 Print the content of the work file
5.2.5 Quit the software
5.2.6 Product recipe (SOP menu)
5.2.7 When you click on the Product recipe menu the following commands appear

File	SOP	Steritest		Utilities
	New SOP ……. Modify SOP ……. Delete SOP …….. Duplicate SOP ……

5.2.8 These commands enable the following actions
5.2.9 Manage the Product recipe contained in a work file
5.2.10 Add a new Product recipe
5.2.11 Modify a Product recipe
5.2.12 Delete a Product recipe
5.2.13 Duplicate a Product recipe
5.2.14 Manage the handling steps of an Product recipe
5.2.15 Add a new handling step
5.2.16 Modify a handling step
5.2.17 Delete a handling step
5.2.18 Print an product recipe

5.3 Steritest menu

5.3.1 When you click on the steritest menu the following commands appear
5.3.2 These commands enable the following actions
5.3.3 Connect to a steritest equinox pump on connection display the product recipe of the steritest equinox pump and compare these product recipes with those in the work file
5.3.4 Update the Product recipe of the connected steritest equinox pump
5.3.5 Access steritest equinox pump configuration backup file management

5.4 Utility menu

5.4.1 When clicked on utility menu the following commands appear
5.4.2 These commands enable the following actions
5.4.3 Change passwords
5.4.4 Access the configuration of the software
5.4.5 ? menu
5.4.6 When clicked on the? menu the following commands appears
5.4.7 These commands enable the following
5.4.8 Access help
5.4.9 Access the characteristics of the software

5.5 Configure the steritest equinox pump to computer communication.

5.5.1 Plug and configure the steritest equinox pump directly to a computer
5.5.2 Connect the computer to the pump power supply with Rj – 45 crossover cable
5.5.3 Switch on the instruments
5.5.4 Press the ON / OFF buttons
5.5.5 The start-up screen appears and the pump head opens
5.5.6 After equipment initialization the initial Testing mode screen is displayed.
5.5.7 Select manual or automatic test
5.5.8 Select the mode by turning the knob, confirms by pressing the knob
5.5.9 Note: from a menu screen hold down the next / back button to the testing mode screen
5.5.10 Installing the consumable
5.5.11 Check that the cover is present on the drain tray
5.5.12 Remove the consumable from its packaging and place the canisters on the drain tray
5.5.13 Install the tubing in the pump head as follows
5.5.14 At the same time gently pull the tubing and engage it fully in the cover
5.5.15 Check that the two tubing hoses are positioned on either side of the bosses on the right and left sides of the cover.
5.5.16 Slide the tubing from left to right and right to left to ensure that it is correctly positioned, If the tubing does not slide freely, repeat the operation.
5.5.17 Make sure that the tubing is not excessively bent on the canister side If necessary slide the tubing to the right in the pump head.
5.5.18 Close the pump by pressing the open/ close button.
5.5.19 Note: The pump head can only be closed after selecting manual or automatic mode.
5.5.20 To remove the tubing from the pump head open the pump head, open the pump head and then pull the tubing gently to release it from the pump head.

5.6 Use in manual mode

5.6.1 Manual mode screen
5.6.2 To program and display the pump rotation speed
5.6.3 To program and display the pump timer from 0 (OFF) to 0.5 to 999
5.6.4 Note: Between 0.5 and 9.9, the displayed is 1 unit and 1 decimal Between 10 and 999 the display is 3 units without decimal.
5.6.5 To display an alert message in the event of high pressure in the canisters
5.6.6 To visualize the pump head status
5.6.7 Operation in the manual testing mode in the following way
5.6.8 Select manual mode by turning the knob, Confirm by pressing the knob
5.6.9 Display the manual mode screen
5.6.10 Turn the knob to change the pump rotation speed
5.6.11 Clockwise to increase the speed, Anti clockwise to decrease the speed
5.6.12 With the pump head open press the open/ close button to close it
5.6.13 Press the knob or the footswitch to start or stop the pump
5.6.14 With the pump head closed to press the open /close button to open it
5.6.15 Press and hold down the next / back button to return to the testing mode screen.

5.7 Operation in automatic

5.7.1 Select manual or automatic mode as follows
5.7.2 Select the mode by turning the knob, confirms by pressing the knob
5.7.3 The list of the product recipe present in the steritest equinox pump is displayed
5.7.4 Select the test procedure by turning the knob and then confirm by pressing the knob
5.7.5 Display the automatic mode screen for the 1st step of the selected Product recipe
5.7.6 Press the knob to activate the pump. The pump speed and the timer are pre-set when the
5.7.7 Pump head is rotating in the timer mode, the timer valve is blinking
5.7.8 Pressing next / back moves onto the next sequence
5.7.9 Note: Press and hold down next/back to return to the previous sequence the pump head can be open and close the pump head at any time, except when the pump is rotating
5.7.10 On the 1st step of the selected product recipe, press and hold down next/back to return to the list of the product recipe present in the steritest equinox pump.
5.7.11 Speed change in product recipe mode
5.7.12 Turn the knob, pump head and timer countdown stops. A screen appears asking for confirmation to change speed
5.7.13 Confirm then change the pump rotation speed by turning the knob
5.7.14 This speed change authorization is active until the transition to the next sequence
5.7.15 Timer change in product recipe mode
5.7.16 The timer value cannot be changed but aborted to stop the pump before the programmed timer value expires press the knob. A confirmation screen appears to select the option by turning the knob and confirm by pressing it
5.7.17 Select continue either with the knob or the footswitch to restart the pump and continue the countdown
5.7.18 Select Abort to reset the valve without restarting the pump
5.7.19 The end of the step is reached when the last sequence of the product recipe is completed Press next
5.7.20 Note: The equipment automatically reverts to the last product recipe
5.7.21 From the testing procedure screen press and hold down the next / back button to return to the testing mode screen

5.8 Switching off

5.8.1 Pressing off will place the equipment on standby and switch off the LCD screen.
5.8.2 If not used for an extended period or in the event of maintenance switch off the steritest equinox pump with the main on-off switch on the front of the power supply unit.
5.8.3 Cleaning of the steritest equinox pump should be done with the scheduled disinfectant.
5.8.4 Before starting the cleaning operation turn the main power supply off with the main on-off switch on the front of the power supply unit
5.8.5 Pump head cover spray on a decontamination solution and clean off with or autoclave at 121°C for 30 minutes
5.8.6 Bottle holder spray on a decontamination solution and clean off with a wipe or Autoclave at 121°C for 30 minutes
5.8.7 Clean the entire unit with isopropyl alcohol and clean with a dry lint free mop

5.9 Equal splitting capacity verification

5.9.1 Prepare five filtered purified water vials with 10 ml, 25 ml, 50 ml, 100 ml & 200 ml (2 x 100 ml) and plug with the rubber stopper and seal it.
5.9.2 Prepare two beakers of the same size and label them as a1 & a2 consider it as set 1, these are for 10 ml.
5.9.3 Similarly prepare beakers for 25 ml, 50 ml, 100 ml & 200 ml and label them as b1 & b2, c1 & c2, d1& d2 and e1 & e2 respectively.
5.9.4 Weigh the beakers and note the readings.
5.9.5 Transfer the material to the pass box (Incubator room to LAL test room).
5.9.6 Enter the room according to SOP for entry and exit in microbiology testing area.
5.9.7 Transfer all the material into pass box (LAL test room to Buffer room).
5.9.8 Enter the ‘sterility test area’ as per SOP.
5.9.9 Enter into the buffer room and collect all the material from the pass box (Buffer room to LAL test room) and transfer it into cRABS pass box.
5.9.10 Install the steritest canister in steritest equinox. Pre-wet the membrane filter with 100 ml of filtered purified water and filter the same.
5.9.11 Keep 10 ml purified water vial on to stand. Make sure the bottom plugs of the canisters are closed.
5.9.12 Insert the canister needle into the purified water vial and pump the liquid into the canister by adjusting the speed 25.
5.9.13 Stop the pump after transferring of the entire solution from the vial.
5.9.14 Disconnect the canister from drain tray, put the red caps on top of the canisters and remove the bottom plugs. Keep on one set of the beakers (a1 & a2).
5.9.15 Run the pump at speed 25 and collect the filtrate in the beakers.
5.9.16 Connect the bottom clamps again and keep the canisters on the drain tray.
5.9.17 Repeat the procedure from point No. 5.9.11 to 5.9.16 with below mentioned sets.

Vial Quantity	Pump Speed	Pump from canister to beaker set
25 ml	50	b1 & b2
50 ml	50	c1 & c2
100 ml	100	d1& d2
200 ml	150	e1 & e2

5.9.18 After completion of the activity transfer all accessories from work chamber of cRAB to the pass box of the cRAB and from pass box of the cRAB to pass box (Autoclave room to Buffer room). Clean the cRAB with the sporicidal agent.
5.9.19 Take care while transport, the liquid should not come out and spill, where it will give erroneous results.
5.9.20 Weigh the beakers with the liquid already transferred and note the readings.
5.9.21 Calculate the % difference with following formula:
% Difference = [1 – C1 / (C1 + C2 / 2)] x 100
C1 = Net weight in grams of the water collected in canister 1 (a1 / b1 / c1 / d1 / e1)
C2 = Net weight in grams of the water collected in canister 2 (a2 / b2 / c2 / d2 / e2)
% Difference = Splitting capacity (difference in percentage compared to average volume)
5.9.22 Acceptance criteria - % Difference must be less than or equal to 10 % of average volume.
5.9.23 Frequency - Once in six months
Note: In case of failure to meet the acceptance criteria, intimate to the Quality Assurance Department to assess the impact and subsequently to service engineer to rectify the problem.

6.0 Abbreviations

6.1 SOP - Standard operating procedure
6.2 % - Percent

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