PM/ IS 13334 Part 2/ 1

May 2020

PRODUCT MANUAL FOR

SKIMMED MILK POWDER PART 2 EXTRA GRADE
ACCORDING TO IS 13334 PT.2:2014

This Product Manual shall be used as reference material by all Regional/Branch Offices &
licensees to ensure coherence of practice and transparency in operation of certification under
Scheme-I of Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 for
various products. The document may also be used by prospective applicants desirous of
obtaining BIS certification licence/certificate.

1. Product : IS 13334 (Part 2): 2014

Title : Skimmed Milk Powder Part 2 Extra Grade

No. of amendments : 1

2. Sampling Guidelines

a) Raw material : Milk intended for production of skimmed milk powder shall
be tested for its freedom from Neutralizers, Preservatives
and adulterants.

b) Grouping Guidelines : NA

c) Sample Size : 2 x 500 g (separate samples for chemical and

microbiological tests) packed in air-tight containers.

3. List of Test Equipment : ANNEX - A

4. Scheme of Inspection and : ANNEX - B

Testing

5. Possible tests in a day : All tests except microbiological tests.

6. Scope of the Licence :

Licence is granted to use Standard Mark as per IS 13334 Pt.1:2014 with the following scope:

Name of the product Skimmed Milk Powder- Extra Grade

Process Spray drying

BUREAU OF INDIAN STANDARDS

ManakBhawan, 9, Bahadur Shah ZafarMarg,
New Delhi – 110002
 ANNEX A
TO PRODUCT MANUAL FOR
SKIMMED MILK POWDER PART 2 EXTRA GRADE
ACCORDING TO IS 13334 PT.1:2014

LIST OF TEST EQUIPMENT

Major test equipment required to test as per requirements of Indian Standard.

S. No. Test Equipment Tests used in with
Clause Reference
0 0
1. -Drying oven capable of being maintained at 87 C+1 C Moisture
throughout the working space, LC 1oC. Cl. 5.7, Table 1
-Metal block
-Copper tubes
-Constant pressure regulator
-Tube, made of polycarbonate
-Columns made of hard polypropylene
-Synthetic stoppers
-Container, suitable for holding columns and synthetic
stoppers
-Rod made of polyvinyl chloride
-Soap-film meter, suitable for measuring a flow of 33 ml/min
-Dry compressed air, minimum pressure of 200 kPa, moisture
content of 0.01 mgH2O per Iitre at atmospheric pressure, free
of any organic material. Use metal tubes only to connect the
source of compressed air to the equipment in the drying oven.
-Analytical Balance, LC 0.1 mg
-Flat bottom moisture dishes with cover
-Desiccator
Screw capped bottles, Durham tubes, test tubes
Sterile blender jar
Inoculating loop, platinum-iridium or nickel-chromium or
disposable loops
Stop watch
Volumetric Flask, 100ml, 250 ml & 1000 ml
2. -Kjeldahl flasks Milk protein in Milk
-Heating device SNF
-Boiling chips or glass beads Cl. 5.7, Table 1
-Concentrated Sulphuric acid
-Mercuric Oxide or Metallic Mercury
-Potassium Sulphate or Anhydrous Sodium Sulphate
-Zinc granules
-Sulphite or Thiosulphate Solution
-Sodium hydroxide
-Hydrochloric acid or Sulphuric Acid, Standard Solution
-Sodium hydroxide standard solution
Methyl Red Indicator
Paraffin or Silicon Antifoam
Analytical balance
distillation assembly and Erlenmeyer flasks
3. Centrifuge with Centrifuge tubes Fat
Butyrometer, 6 Percent, 8 Percent and 10 Percent Scale with Cl. 5.7, Table 1
stopper
Pipettes
Analytical Balance, 0-500 g, LC 0.1 g
Water bath, upto 100°C, LC 0.1°C
Sulphuric acid
Amyl alcohol
Stemless -Funnel
Wash bottle
Glass rod
Grater or Pestle and Mortar
Scoop
Camel hair brush
4. Silicon antifoaming agent Insolubility index
Thermometers for measuring 24°C and 50°C, error +0.2°C Cl. 5.7, Table 1
max
Water bath, upto 100°C, LC 0.1°C
Scoop
Analytical balance LC 0.01g
Electric mixer
Interval timer
Centrifuge with Centrifuge tubes
Siphon fitting or suction tube attached to water pump
Scoop
Camel hair brush
Stirring rod
Magnifying glass

5. -Flat-Bottom Dish, of stainless steel, porcelain, silica or Total Ash

platinum Cl. 5.7, Table 1
-Muffle Furnace upto 1200°C, LC 1°C
- Desiccator
-Air-Oven, capable of maintaining 100oC + 2oC, LC 1oC
-Flame for pre-heating
- Analytical Balance
6. -Heater for boiling water Titrable Acidity
- Analytical balance Cl. 5.7, Table 1
-Sodium hydroxide
-Phenolphthalein solution
Porcelain Dishes
-stirring rods
Potassium hexacyanoferrate(II) solution Lactate content
Zinc sulfate solution Cl. 5.7, Table 1
Sodium hydroxide solutions
Glycerol solution
Ammonium sulfate solution
Buffer solution, pH 10.
Nicotinamide adenine dinucleotide solution (NAD).
L-Lactate dehydrogenase (L-LDH)
D-Lactate dehydrogenase (D-LDH)
Glutamate pyruvate transaminase (GPT)
Lithium L-lactate solution
Lithium D-lactate solution
 Analytical balance, capable of weighing to the nearest 1 mg,
LC 0.1 mg.
Glass beaker
Graduated cylinder
One-mark volumetric flasks, of capacity 100 ml
Pipettes, capable of delivering 0,02 ml, 0,05 ml, 0,2 ml, 1,0
ml and 2,0 ml
Graduated pipettes, capable of delivering 5 ml and 10 ml,
graduated in 0,1 ml divisions.
Glass filter funnel, of diameter about 7 cm
Filter paper, medium fast grade, of diameter about 15 cm, free
from lactic acid and lactates
Glass rod
Plastic paddles, capable of mixing the sample-enzyme
mixture in the spectrometric cell
Spectrophotometer, capable of measuring at 340 nm,
equipped with cells of optical path length 1 cm
Parafilm
7. Scorched particles filtering discs Scorched particles
Scorched particles Discs test cards Cl. 5.7, Table 1
Scorched particles tester
Scorched particles standard photoprints for dry milk
Analytical Balance, 0-500 g, L C 0.1 g
Waring blender
Defoaming agent
8 Plate count agar Bacterial count
Overlay medium Cl. 5.7, Table 1
Oven
Autoclave
Incubator (30o C+1oC
Petri dishes
Water bath
Colony counter
pHmeter
test tubes, flasks/bottles
Filtration assembly and filter paper
Laminar Air Flow Bench
9 Crystal violet neutral red bile lactose (VRBL) agar Coliform count
Brilliant green lactose bile broth Cl. 5.7, Table 1
Oven or Autoclave
Incubator, 30Oc+ 1Oc or 37oC+1oC
Petri dishes
Total delivery plates
Water bath, 44Oc TO 47Oc or 100oC
Colony counter
Test tubes
Durham tubes
Bottles or flasks
pHmeter
loop
Filtration assembly and filter paper
Laminar Air Flow Bench
10 Nutrient broth E.coli
Nutrient agar Cl. 5.7, Table 1
MacConkey Agar medium
 MacConkey broth medium
Eosin methylene blue lactose agar medium
Tergitol-7 agar medium
Nutrient agar mediem for motility test
Tsi medium for H2S test
Medium for ureas test
Medium for indole production
Medium for methyl red and voges Proskauer tests
Simmon’s citrate agar
Peptone water medium for carbohydrate fermentation test
Filtration assembly and filter paper
Laminar Air Flow Bench
BOD Incubator, 5 -50oC, LC 0.1oC
11 Nutrient broth Coagulase positive
Nutrient agar staphylococcus aureus
Blood agar Cl. 5.7, Table 1
Salt medium
Baird parker medium
Ethyl violet azide dextrose broth
MacConkey agar medium
Filtration assembly and filter paper
Laminar Air Flow Bench
12 Buffered peptone water Salmonella
Rappaport-vassiliadis magnesium chloride/malachidte green Cl. 5.7, Table 1
medium (RV medium)
Selenite/cystine medium
Solid selective plating-out media
Phenol red/brilliant green agar
Nutrient agar
Triple sugar/iron agar
Urea agar
L-Lysine decarboxylation medium
Reagent for detection of β-galactosidase
Reagents for Voges-Proskauer (VP reaction)
-VP medium
-creatine solution
-1-Naphthol
-Potassium hydroxide solution
-Reagents for indole reaction
Water bath
Loops
pHmeter
culture bottles and flasks
culture tubes
measuring cylinders
graduated pipettes
petri dishes
Filtration assembly and filter paper
Laminar Air Flow Bench
13 Dilution fluid Aerobic (Bacillus cereus)
Agar medium Cl. 5.7, Table 1
Base medium
Polymyxin B solution
Egg yolk emulsion
Sheep blood agar
 Oven or autoclave for sterilization
Drying cabinet or incubator capable of operating between 37
°C ± 1 °C and 55 °C ± 1 °C.
Incubator, capable of operating at 30 °C ± 1 °C. 6.4 Water
baths, capable of being maintained at 44 °C to 47 °C.
pH-meter, accurate to within ± 0,1 pH units at 25 °C.
Petri dishes
Graduated pipettes
Spreaders
Colony counter Filtration assembly and filter paper
Laminar Air Flow Bench
14 Plate count medium Anaerobic (sulfite
Saline peptone diluent reducing clostridia)
Incubator - capable of being maintained at 37+1°C. Cl. 5.7, Table 1
Volumetric pipettes
Test tubes
Water bath (thermostatically controlled)
15 Lithium chloride Listeria monocytogenes
acriflavine and nalidixic acid (half fraser broth) Cl. 5.7 Table 1
Fraser broth
Oxford agar
PALCAM agar
Selective solid plating-out media
Tryptone soya yeast extract agar (TSYEA)
Tryptone soya yeast extract broth (TSYEB)
Sheep blood agar
Carbohydrate utilization broth (rhamnose and xylose)
Motility agar
Laminar Air Flow Bench
CAMP (Christie, Atkins, MunchPetersen) medium and test
strains
Hydrogen peroxide solution
Phosphate-buffered saline (PBS)
Oven or autoclave for sterilization
BOD Incubator, 5 -50oC, LC 0.1oC
Water bath, capable of being maintained at 47 ‘c t 2 ‘c.
Loops
pH meter
test tubes or flasks
measuring cylinder
Filtration assembly and filter paper
List above is only indicative and may not be taken as exhaustive
 ANNEX B
TO PRODUCT MANUAL FOR
Skimmed Milk Powder Part 2 Extra Grade
According to IS 13334 (Part 2) : 2014

SCHEME OF INSPECTION AND TESTING

1. LABORATORY - A laboratory shall be maintained which shall be suitably equipped (as per the
requirement given in column 2 of Table 1) and staffed, where different tests given in the specification
shall be carried out in accordance with the methods given in the specification.

1.1 The manufacturer shall prepare a calibration plan for the test equipment.

2. TEST RECORDS – The manufacturer shall maintain test records in various formats, Form 1 for
the tests carried out to establish conformity.

3. LABELLING, PACKINGAND MARKING–– Labelling and marking shall be as given below:

3.1 STANDARD MARK: The Standard Mark, as specified by BIS, shall be stencilled with indelible
ink or printed on labels applied to the container of skimmed milk powder provided always that the
material in each container to which this mark is applied conforms to every requirement of the
specification.

3.2 MARKING - As per the requirements of IS 13334 Pt.2: 2014.

3.2.1 In addition to above, following marking shall also be marked:

a) Any other marking required under provisions of Legal Metrology Act, 2009 and Legal
Metrology (Packaged Commodities) Rules, 2011 framed thereunder.
b) In case of flexible pack, the following information shall be marked on the label:‘Once opened,
the entire product content should immediately be placed in a clean air-tight container’.
c) BIS Licence No. CM/L………………….
d) BIS website details i.e –“For details of BIS certification please visit www.bis.gov.in”

3.3 PACKING: The material shall be packed as per cl. 6.1 of IS 13334 (Part 2):2014

4. CONTROL UNIT–

4.1 For the purpose of this Scheme, the entire quantity of milk powder manufactured continuously at
a time in a period of 24 hours or a part thereof shall constitute a control unit.

4.1.1 Raw Milk: The raw milk received in factory shall be tested for fat, SNF, COB, Neutralizers,
Additives, etc, and appropriate records maintained. Milk intended for production for skimmed milk
powder shall be tested for freedom from Neutralizers, Preservatives, Adulterants and necessary
records maintained.

5. LEVELS OF CONTROL - The tests as indicated in column 1 of Table 1 and the levels of control
in column 3 of Table 1, shall be carried out on the whole production of the factory which is covered
by this plan and appropriate records maintained in accordance with paragraph 2 above.
5.1 On the basis of test and analysis results decision regarding the conformity or otherwise of a control
unit of skimmed milk powder to the requirements of the specification shall be made as follows:

5.1.1 A sample shall be taken at the packing stage after every half an hour which shall be examined
visually for appearance, colour, absence of lump and extraneous matter; examined by organoleptic
methods for flavour and taste, absence of added colour & added flavour and analysed for moisture
content. If the sample does not conform to the specification in any one or more of these requirements,
the material manufactured during the half an hour prior to the drawl of sample shall either be rejected
or reprocessed and the defect(s) rectified. Such reprocessed material when tested again shall conform
to all the requirements of the specification.

5.1.2 Two samples shall be drawn from every control unit – one during the first half of the packing
period and other during the second half of the packing period. These samples shall be individually
tested for Milk Protein in Milk Solids not fat, Insolubility index, Milk fat, Titrable acidity, Scorched
particles, Bacterial count, Coliform count & Escherichia coli. If any one or both the samples fail to
conform to anyone or more of these requirement(s) as given in the specification, the entire material
in the control unit shall not be marked. In case of manufacturers, the material may, however, be
reprocessed and the defect(s) rectified. Such reprocessed material when tested again shall conform to
all the requirements of the specification.

5.1.3 Two samples from every seventh control unit (starting from a control unit chosen at random)
shall be tested for total ash. If any one or both the samples fail to satisfy the requirement, the
corresponding control unit shall not be marked. The material in the control unit may, however, be
reprocessed and the defect rectified. Such reprocessed material when tested again shall conform to
all the requirements of the specification. Two samples from every subsequent control unit shall be
tested for the characteristic where failure has occurred till seven consecutive control units are found
meeting the specification requirement, whereupon the original frequency of testing may be resumed.

5.1.4 Two sample(s) for Lactate content and one sample each for testing of and Coagulase Positive
Staphylococcus aureus, Salmonella, Spore Count a) Aerobic (Bacillus cereus), b) Anaerobic (sulphite
reducing clostridia), and Listeria monocytogenes shall be drawn from the product every month for
testing as given under Table-2 of this scheme. In case of failure of the sample in any one or more of
these characteristics the corresponding control unit shall not be marked and two samples from every
subsequent control unit shall be tested for the characteristic(s) where failure has occurred, till five
consecutive control units are found meeting the specification requirement(s) whereupon the original
frequency of testing may be resumed.

Note: The requirement for pathogens (like Salmonella, etc) shall be tested in a laboratory situated
away from the production area or in an outside recognised lab.

5.1.5 Skimmed Milk Powder shall be the material prepared by spray drying of fresh skimmed milk
of cow or buffalo or a combination thereof.

5.1.6 The product may contain added calcium chloride, citric acid and sodium citrate, sodium salts of
orthphosphoric acid and polyphosphoric (as linear phosphate), not exceeding 0.3 percent by mass of
the finished product.

5.1.7 All processing and drying should be carried out in a manner that minimizes loss of nutritive
value, particularly protein quality.

5.1.8 Undertaking w.r.t clause 5.8 of ISS to be submitted by the manufacturer stating that it shall be
the responsibility of the manufacturer/repacking unit to comply with the relevant requirements as per
Food Safety and Standards (Contaminants, toxins and residue) Regulations, 2011 and maintain
records of the conformance.
6. HYGIENIC CONDITIONS – The material shall be manufactured packed, stored and distributed
under hygienic conditions (see IS 2491). All the processing equipment should be properly cleaned
and care should be taken to prevent infestation.

7. REJECTIONS–Disposal of non-conforming product shall be done in such a way so as to ensure

that there is no violation of provisions of BIS Act, 2016.
 TABLE 1
LEVELS OF CONTROL
(1) (2) (3)
Test Details Test equipment Recommended Levels of Control
Cl. Requirement Test Methods requirement No. of Frequency Remarks
Clause Reference R: required (or)S: Sample
Sub-contracting
permitted
4 Description 4 IS 13334 (Pt 2) R One Every half an hour See clause
5.1.1 of SIT
5.2 Freedom from 5.2 -do- R One -do- -do-
extraneous matter,
added colour & added
flavour
5.4 5.4 -do- R One -do- -do-
Flavour and Taste
5.7 & - IS 11623 or IS R One -do- -do-
Table 1 Moisture 16072
-do- - IS 7219 R Two Each Control Unit See Cl. 5.1.2 of
Milk Protein in milk SIT
solids not fat
-do- - IS 11721 or R Two -do- -do-
Milk Fat Annex IS 13334 (Pt 1)
B
-do- - IS 12759 R Two -do- -do-
Insolubility Index
-do- Annex IS 14433 R Two Every 7th Control See Cl. 5.1.3 of
Total Ash (On dry B Unit SIT
-do- basis) - IS 11766 R Two See Cl. 5.1.2 of
Each Control Unit SIT
-do- Titrable Acidity - IS 11202 S Two See Cl. 5.1.4 of
Once in a month SIT
-do- Lactate Content - IS 13500 R Two -do-
Each Control Unit
Scorched Particles
 TABLE 1 (Contd.)

(1) (2) (3)

Test Details Test equipment Recommended Levels of Control
Cl. Requirement Test Methods requirement No. of Frequency Remarks
Clause R: required (or)S: Sample
Reference Sub-contracting
permitted
5.7& Bacterial Count - IS 5402 R Two Each Control Unit See Cl. 5.1.2 of
Table SIT
1 Coliform Count - IS 5401 (Part 1) R Two -do- -do-
-do-
Escherichia coli - IS 5887 (Part 1) R Two -do- -do-
-do-
Coagulase positive - IS 5887 (Part 2) S One Once in a Month See Cl. 5.1.4 of
-do- Staphylococcus aureaus SIT

Salmonella - IS 5887 (Part 3) S One -do- -do-

-do-
Spore Count -
-do- a) Aerobic (Bacillus IS 5887 (Part 6) S One -do- -do-
cereus)
b) Anaerobic (Sulfite - ISO 15213 S One -do- -do-
reducing clostridia)
- IS 14988 (Part 2) S One -do- -do-
-do- Listeria mono cytogenes

Notes: 1. The requirement for pathogens (like Salmonella, etc) shall be tested in a laboratory situated away from the production area or in an
outside recognised lab.
2. Whether test equipment is required or sub-contracting is permitted in column 2 shall be decided by the Bureau and shall be mandatory. Sub-
contracting is permitted to a laboratory recognized by the Bureau or Government laboratories empanelled by the Bureau.

3. Levels of control given in column 3 are obligatory to which the licensee shall comply with.