LAB-080 Preparation of Disinfactant solution IPA

1. Distilled Water

1.1. Distilled Water that is used in the preparation of solutions must be freshly collected from the distilled water outlet.

1.2. Distilled Water may be used to clean the machines.  The water is in a spray bottle with a Blue nozzle. It is to be used only in Grade D areas, NOT for Sterile areas.

Water must be collected at the time it is required and emptied when finished as it has a ONE-DAY EXPIRY.
Every time the bottles are filled with Distilled Water, place an Expiry Date sticker on the bottle.  Write the Expiry Date on the sticker, e.g.

Date of Filling: dd/mm/yy              Expiry on the bottle: dd/mm/yy

2. Alcohol IPA

The alcohol used, IPA, (Iso-propyl alcohol, propan-2-ol) is obtainable from the Flammable Goods cabinet in a 20L drum.

3. Issuing Codes for Sterile disinfectants and containers:

* ‘Target’ (commercial brand) is used for cleaning in Sterile areas

4. Spray Bottles

The spray bottles for 70% IPA are supplied in two (2) different spray nozzle colours.

4.1. RED spray nozzles are for general use and for cleaning in Environmental Grades C, D, 2 and 1 (solid dose Plant).

4.2. Bottles with the Red nozzle will be labelled specifically for use in each Sterile airlock to avoid using bottles with the White nozzles in a Grade C area.

4.2.1. Bottles with the RED nozzle that are used in the Sterile Airlocks are NOT TO BE TAKEN INTO THE STERILE AREA and be re-filled.  When empty, the Sterile Operator should contact a Production Operator to re-fill the bottles using the IPA vessel.

4.3. WHITE spray nozzles are to be used INSIDE STERILE ONLY, Environmental Grade B.

4.4. If a White spray nozzle, with bottle is found outside environmental grade B, the Production Operator should be notified and the bottle discarded.  Under NO circumstances can the bottle be reused.

4.5. Clean Room Garments are to send the White nozzle spray bottles to the site Warehouse already rinsed with Distilled Water, dried and sterilised via Ethylene oxide.

4.6. Production personnel will then issue the White nozzle spray bottles from the site Warehouse to Production for use in Sterile.

4.7. If dirt or foreign matter is found inside the Alcohol spray bottle, or the outside is badly soiled by paint or ink – discard the spray bottle.

5. Disinfectants

Disinfectants used on critical surfaces or gloves in Sterile areas are to be supplied Sterile filtered.  Therefore ALL 70% IPA SOLUTIONS USED IN THE STERILE FILLING AREAS MUST BE FILTERED THROUGH A STERILE, STERILISING FILTER.

6. Containers for Disinfectants

Containers for Disinfectants should not be topped up.  Before filling Bioprep containers, they must be rinsed with Distilled Water until there are no traces of soap and Distilled Water must be pumped through the pump until it runs clear.

Microshield uses a new bottle but the pump must be cleaned the same way as the Bioprep pump.  Before filling 70% IPA spray bottles, they should be emptied of all remaining alcohol and any alcohol in the nozzle must be pumped out.

7. Preparation of Sterile Filtered 70% IPA (% volume/volume)

7.1. Weigh one new 20L drum of IPA on the moveable Floor Scale.
Note the following in the 70% IPA Preparation Logbook:

a. The area where the IPA is issued

b. The full drum weight

c. The Product Code of the IPA

d. The date of preparation and the Manufacturer’s batch number from the drum.

e. The logbook covers the IPA preparation areas

7.2. Close the valves, release pressure from the vessel using the spring loaded release valve.  Remove the pressure gauge and empty the contents of the IPA drum into the 40L Pressure vessel.

7.3. Weigh the empty new drum of IPA and calculate the amount of IPA filled into the Pressure vessel.  The drum normally contains 20L of IPA = 15.6Kg of IPA,

For example:

Full drum weight         17.55Kg (gross)
Empty drum weight     – 1.83Kg (tare)
IPA weight                  15.72Kg (net)

Note in the logbook: (1) The weight of the empty drum and (2) the calculated net weight.

7.4. Calculate the amount of water needed to make the 70% solution of IPA using the following formula:

Kg water = 0.544 x Kg IPA filled into the 40L vessel.

The result is usually near 8.5Kg of water,

e.g. 15.72Kg IPA was filled into the 40L vessel.

The amount of water should be:

0.544 x net wt IPA = 0.544 x 15.72Kg = 8.55Kg water.

7.5. Place the dedicated plastic bucket on the floor scale and ZERO the scale.

7.6. Weigh out the calculated amount of Distilled Water into the plastic bucket and then transfer it into the 40L vessel.
Note the weight of the Distilled Water in the logbook.

7.7. Mix for 5 minutes using the manual mixer.

7.8. Place the pressure gauge onto the 40L vessel.

7.9. Once the gauge is in place on the vessel, the valve on the vessel must be in the OPEN position then turn air ON at the Nitrogen line.

NOTE   Air pressure regulator set between 30 psi = 2 Bar (minimum) to 60 psi = 4 Bar (maximum).  Ensure the valve on the dispensing pipe is in the CLOSED position.  When the vessel has the correct quantity of pressure in it, the valve on the vessel must be CLOSED so that the dispensing pipe valve can be opened to fill bottles.

7.10. To remove any air or old 70% IPA from the line, fill 2 Spray bottles using the new 70% IPA solution and discard.

7.11. Place the float gauge (Hydrometer) carefully into the measuring cylinder. Fill the measuring cylinder to approx. 100mL with the new 70% IPA solution. Read the density on the float.  The IPA solution is acceptable if the reading is within:

859 – >883         (0.859 – 0.883g/mL = 65 – 75% v/v IPA)

Note the Density reading in the logbook

NOTE   The float gauge reads in descending order so care should be taken when reading.  If the Density is not correct, contact your Manager.

7.12. Rinse the measuring cylinder and float in cold Distilled Water.

7.13. Using an Expiry Date Sticker, stick it on the 40L vessel and write on it the Expiry Date that is one (1) month from the date of preparation.  

Note the Expiry Date in the logbook.

7.14. Remove/Deface the labels from the empty IPA drum and place in WIP for the warehouse staff to dispose of them.

7.15. Upon Completion of 70% IPA manufacture, an aseptic 100mL sample is to be collected into a sterile 100mL flat bottle supplied by the Micro. Lab.

7.16. The bottle is to be labelled with the following with a permanent marker:

a. 70% IPA

b. Manufacture date

c. Expiry date

d. Production area name.

7.17. The sample is to be placed on to the designated shelf of the Micro. The Micro. Lab. is to test the sample as per procedure.

8. Sterile Operators filling procedure for WHITE nozzle spray bottles

8.1. Firstly check that the Expiry Date labelled on the vessel is one (1) month from the date of preparation.

8.2. Remove the old Expiry Date sticker on the white nozzle spray bottle and replace it with a new Expiry Date sticker.  Use the ‘For Sterile Use Only’ Expiry Date stickers. The expiry date on the vessel is the date you will need to write on the expiry sticker for the spray bottle.

8.3. Empty the spray bottle of any remaining 70% IPA prior to refilling.  Also, activate the pump a few times to empty the nozzle.  1/3 fill the spray bottle with the fresh 70% IPA, swirl the bottle ensuring all the internal surface has been rinsed and dispose the 70% IPA.  This is to clean the internal surface of the spray bottle before refilling with the fresh 70% IPA.

8.4. Fill the White nozzle spray bottle with sterile filtered 70% IPA from the vessel inside Sterile.  Make sure that the nozzle on the IPA bottle is on “SPRAY” position after the bottle has been filled.

8.5. When the vessel is empty, contact a Production Services operator to re-fill the vessel.

9. Filling Procedure for Red Nozzle Spray Bottles (Grade C, D & Class I)

9.1. Firstly, check that the Expiry Date labelled on the vessel is one (1) month from the date of preparation.

9.2. Remove the old Expiry Date sticker on the Red nozzle spray bottle and replace it with a new Expiry Date sticker.  The Expiry Date on the vessel is the date to be written on the Expiry Date sticker for the spray bottle.

9.3. Empty the spray bottle of any remaining 70% IPA prior to refilling.  Also, activate the pump a few times to empty the nozzle.  1/3 fill the spray bottle with the fresh 70% IPA, swirl the bottle ensuring all the internal surface has been rinsed and dispose the 70% IPA.  This is to clean the internal surface of the spray bottle before refilling with the fresh 70% IPA.

9.4. Fill the Red nozzle spray bottle with sterile filtered 70% IPA from the vessel .

9.5. Make sure that the nozzle on the IPA bottle is on “SPRAY” position after the bottle has been filled.

10. 70% IPA is used as follows:

10.1. In Spray Bottles both inside and outside the Sterile Area airlock.

10.2. For Disinfection of equipment, machine parts, etc. in the Airlock before being taken into the Sterile Area.

10.3. By Sterile Area Operators: Gloves are to be sprayed regularly with 70% IPA – approximately every 10 minutes, before entering any LAL area and before and after handling equipment.

10.4. For Daily disinfection of equipment, machines, benches, etc.

10.5. Micro-Lab Usage: Dispensary of 70% IPA for Micro-Lab

Micro-Lab send to the Washroom 2L autoclaved bottles, which are filled to 1800ml.
Production Services fill the empty bottles with 70% IPA and leave the bottles in the Washroom on the back bench for pick up by the Micro-Lab personnel.

11. Labelling and Expiry Dating

11.1. All bottles containing 70% IPA, Microshield (brand) or Bioprep (brand) are to be clearly and adequately labelled with the disinfectant solution and the Expiry Date.

The expiry date for all solutions is one (1) month from the date of preparation/date of opening the bottle,

e.g: Date of Preparation/Opening:    dd/mm/yy    Expiry Date:     dd/mm/yy

11.2. The Sterile Area vessels 70% IPA MUST also be clearly labelled with the expiry date by the Production Operator.

11.3. Each bottle of Microshield and each box of Bioprep have a manufacturer’s stamped Expiry Date.  Check this date on each bottle/box before distribution to ensure that the one (1) month Expiry is within this date.

To label the Microshield bottles, write directly on the bottle with a permanent marker.

To label the Expiry Date on Bioprep containers, place an Expiry Date sticker on the container and write the Expiry Date on the sticker.  Each time a new pouch of Bioprep is put into the container, remove the sticker and replace with a new sticker.

11.4. Red nozzle bottles for 70% IPA have an expiry date sticker.

12. Sterile Filter

12.1. Millipore filter type OPTISEAL DURAPORE.

12.2. The function of this filter is to remove impurities from the 70% IPA solution, including bacteria.

12.3. Testing of the filter is carried out to prove the integrity of the filter.

12.4. The filter assembly must be tested once every fortnight using the ITX Integrity Testers.

12.5. The IPA filters are tested/autoclaved approximately 6 times (i.e. every fortnight for 3 months) then discarded at the end of the three months usage after it has been tested then a new filter is installed.

12.6. When a new filter is installed, the Operator must place two pieces of autoclave tape on the filter housing.  On the first piece, it needs to have written on it “Installed:” and the date of installation.  The second piece needs to have written on it “S/N:” and the serial number of the filter.  The serial number is found on the filter.  Use a Black permanent marker to write on the autoclave tape.

NOTE:  When the new filter is installed, it must be autoclaved, but not tested, before its first use.

12.7. Following the Integrity test, the filter assembly and the dispensing pipe must be re-autoclaved before use.