/ Document type:
Procedure / Field /Sub-field: Quality insurance and risk management / hand hygiene / Date: 30.03.2015
PRODUCTION SHEET

INSTITUTION NAME AND production UNIT

alCOHOL-BASED HANDRUB SOLUTION

whO-RECOMMENDED FORMULATION 1

Batch No / Amounts / Date / Operator
E.g.: 19pg14e08 / ………Bottles of…….mL

Batch numbers are for example assigned in chronological order of production, by identifying the production unit and the day, month and year of production. The month of production can be designated by a letter (between A and L) in alphabetical order.

Example: the batch number above corresponds to the 19th batch hospital of the G point produced on May 14, 2008

1.COMPOSITION

RAW MATERIALS / AMOUNTS
(in mL) / VISA / DOUBLE CHECK
Identification / measure / Identification / measure
Description / Batch number / Analysis control N° / 10 litres
1 / Ethanol ……… %
(Ethanol 96%) / ……………mL
(8333 mL)
2 / Hydrogenperoxide 3% / 417 mL
3 / Glycerol 98% / 145 mL
4 / Sterile distilled or boiled cold water / qsp ad for 10 litres

C.f. 4.1 instructions

Description / Amounts / Description / Amounts
Preparation equipment / Packaging equipment
Alcoholmeter Gay LUSSAC (with v/v scale) / 1 / 100 mL bottles / 100
Large volume container / 2* / Leak-proof screw tops / 100
Measuring beaker of 5 litres / 2 / Self-adhesive labels (format 5cm/5.6cm) / 100
Measuring beaker of 2 litres / 1
Measuring cylinder of 500 mL / 2
Measuring cylinder of 250 mL / 1
Measuring cylinder of100 mL / 1
Funnel (200mm ofØ, short stem) / 1
Funnel (50mm ofØ, short stem) / 2
Non sterile gloves (several sizes) / q.s
Spatula (if final container without screw top) / 1
Plastic safety glasses / 1

2.EQUIPMENT

* Recommended, in case of breakage

- for the final solution: a 20Litre bucket with a tap or a stainless steel container with a lid (of sufficient size to allow mixing without spilling)

- a 20 litre bucket with a tap or a large container for distilled water or boiled cold water

3.CLOTHING

The operator must wear the following clothing during the alcohol-based handrub production:

  1. Long-sleeved shirt, clean and fastened
  2. Hairnet
  3. Safety glasses
  4. Non sterile gloves

The operator should also follow hygiene and security rules during the preparation.

4.PREPARATION

4.1instructions

Set-up

4.1.1Before, during and after production, it is essential to work in an ordered, methodical and tidy way.

4.1.2Before starting production, check that the factory line is clean. That is to say, ensure that the working area is completely clear of any unnecessary raw ingredients and materials, and that it has been cleaned with alcohol.

Equipment

4.1.3Set out all the equipment needed for production and check that it is clean. If necessary, calibrate the final container for the volume of 10 liters and draw a mark on it (engraving this mark is recommended to prevent its erasal by alcohol or other substances).

Raw ingredients

4.1.4Set out on the workplace the ingredients required for production in the necessary amounts.

4.1.5Check that the names and quantities are consistent with the manufacturing documents and check their validity (expiration dates in relation to the period of use of the finished product).

4.1.6Note on the production sheet the batch number and the compliant analysis number of every raw ingredient used in the production, including the verificationof the alcohol concentration using the alcoholmeter Gay LUSSAC.

Measures

4.1.7Every measure should be checked by a second person of the unit (visual double check and double visa)

To read the volume set your sight horizontally at the base of the meniscus and read the result of the graduation measurement. (see figure on the right).

Documentation

4.1.8Fill in and sign the correponding boxes on the production sheet as you go along.

4.1.9Record anyanomaliesobservedon the back ofproduction sheet.

4.2METHOD of operation

4.2.1MEASURING

  1. Hydrogen peroxide 3%:

Measure 417 mL of hydrogen peroxide 3% in a 500 mL measuring cylinder(use a small funnel or a beaker for the transfer processes)

  1. Glycerol 98%: Use a funnel or a beaker and try to avoid letting the viscous glycerol run down the sides of the cylinder. Wait until all the bubbles formed have risen to the surface in order to be able to note the exact level of glycerol in the measuring cylinder.

Measure 145 mL of glycerol 98% into a 250 mL graduated measuring cylinder

  1. Ethanol:always check the ethanol’s alcohol content by using an alcoholmeter. If the measured percentage of alcohol is less than 96 % (WHO formulation), calculate the new amounts of ethanol and distilled water (or boiled cold water) by using the table given in annex.

Measure8333 mLof ethanol96%as follows:

-5000 mL of ethanol 96% in a 5 litre measuring jug

-3000 mL of ethanol 96% in a 5 litre measuring jug

-333 mL of ethanol 96% in a 500mL measuring cylinder

  1. Sterile water or boiled cold water:

If distilled water is not available, boil water for 15 to 20 minutes and let it cool to room temperature (between 15-25°C).

The added amount of water must bring the total volume to 10 litres. If using ethanol 96%, measure 1105 mL of distilled water (or boiled cold water) into a 2 litre measuring jug

If using a different concentration of ethanol, the required volumes of alcohol and water are to be changed. (see document: “Component amounts based on initial alcohol content”)

4.2.2 MIXING

  1. If using a plastic container with tap, check that the tap is closed.
  2. Pour into the container
  3. The measured quantity of glycerol 98% and then rinse the cylinder that was used for the glycerol with some ethanol (using ethanol from the amount already measured), until all glycerol residues have been removed.
  4. The measured quantity of hydrogen peroxide 3%
  5. Add boiled cold water or distilled water
  6. Gradually incorporate, the measured amount of ethanol (in 3-4 additions), and mix well between each addition (homogenization).
  7. Mix the solution:
  8. Close the container with the screw cap as quickly as possible to prevent any evaporation and then gently mix by shaking the recipient for 5 minutes.
  9. If no container is available with a screw cap, mix the solution with a spatula for 5 minutes then cover the container with a lid to prevent evaporation.
  10. Check the final volume of the solution and if necessary complete to the desired volume with water (due to solution contraction of water / alcohol mixture) and mix again
  11. Tidy up and clean the work place, as well as the equipment used

5.PAckAging and labelling:

5.1Packaging

Distribute the solution immediatelyinto bottles.

Amounts per bottle: 100 mL (pocket size)

-Check that the factory line is clean. That is to say, ensure that the working area is completely clear of any unnecessary raw ingredients and materials, and that it has been cleaned with alcohol.

-Use a beaker to transfer the solution into a measuring cylinder.

-Measure 100 mL of solution in a 100 mL measuring cylinder, and then pour the 100 mL into an individual bottle.

-Immediately close the bottle by tightly screwing a cap on it.

-Repeat these operations until all of the prepared quantity of solution has been packaged.

-Tidy up and then clean the workspace with alcohol.

5.2LABELLING

-Check that the labelling table is free of any other labels or equipment before starting

-Use self-adhesive labels preferably or appropriate adhesive

-Check that the label includes all required information, namely: Name of institution, Preparation name, ingredients and concentration, batch number and expiration date, instructions for use, precautions and warnings

-Stick a label on each bottle, in a way that ensures that the information is legible

-Stick a label of the manufactured batch on the production sheet.

-Note the number of prepared labels, and the number of labelsactually used.Destroy any unused labels, in order to be sure not to stick them by mistake on another product, and thus reducing the potential for error.

Number of prepared labels
Number of used labels
Number of destroyed labels

6.CLEANING OF PRODUCTION EQUIPMENt:

Clean equipment with water and liquid soap, then rinse well to avoid soap residues or marks. Allow it to dry in a basket(upside-down, opening facing downwards) before putting away.

Date and Visa

7.ExpirAtION date:

The expiration date is 2 years from the manufacturing date.

8.Storage conditions: room temperature (15-25°C)

9.Quarantine:

-Once labelled, put the entire batch into quarantine (= every bottle) for at least 72 hours in order to allow the destruction of any spores that may be present in the alcohol and on the surfaces of the bottles.

-Identify the quarantined batch using an identification form.

-Place the quarantined batch in a separate and identified area in order to avoid any risk of use before release of the batch.

Date of entry in quarantine / Visaoperator

10.Quality controle analysis

Total number of units to be analysed / 4
Samples to be archived / 4*

Note: It is generally advisable to analyse the first and last bottlesfilled and one or 2 bottle (s) in the middle.

* In good manufacturing practices, a numberof bottles (the same amount as for the analysis) can be kept for example 1 year after the expiration date under the same conditions as product storage, in order to be able to reanalyse the batch (archiving). See if local conditions make it possible to follow this recommendation.

11.NUMBER OF UNITS MANUFACTURED

Total manufactured / Entry in storage / Visa / Date
Eliminated due to defect
Samples for analysis and archives
Placed in storage

12.reLEASE OF THE PRODUCTION

Date / Visa
Production / Operator
Quality control / Laboratory
End of quarantine / Quality control manager
Authorisation from responsible person / Production manager

ATTACH THE ANALYTICAL REPORT TO THE PREPARATION SHEET

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