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J A N U A R Y - 2006

MANUFACTURING A QUALITY PREMIX

A premix is a mixture of vitamins, Quality assurance is a proactive, Premix manufacturing process
trace minerals, medicaments, feed continuous system for monitoring comprises:
supplements and diluents. It is a reproducibility and reliability of a A. Raw Materials
value added solution for feeds with product. It encompasses all the 1. Selection & Specifications
sustainable safety and quality. The activities undertaken to ensure 2. Purchase
premix industry is charged with the predetermined standards of a
3. Receipt & Storage
responsibility of manufacturing a quality premix. Good manufacturing
4. Sampling & Analysis
high quality premix consistently, practices covers all the areas of the
5. Processing
efficiently and economically. Its production process like personnel,
main objective is to deliver the micro facilities, raw materials, quality B. Formulation
ingredients in a manner desired by assurance checks, inventory C. Weighing
the consumer. control, processing, mixing, D. Mixing
Premixing has progressed from packaging and delivery. E. Packaging
the simple hand mixing of several Some premix plants are F. Labeling
ingredients to mechanical mixing, to designed for specific functions, G. Storage of Finished Premix
continuous mixing, and now to such as making poultry premix
A. RAW MATERIALS
computer controlled mixing. exclusively; others are designed for
1. Selection & Specifications
However, the basic concept of producing a variety of premixes for
Vitamins and trace minerals are
mixing ingredients together to result other segments as well. Regardless
available in different forms and their
in a homogeneous blend has of the specific purpose of a premix
bioavailability varies between
remained unchanged. plant, material flow follows a basic
sources. Amongst vitamins the
The principles of quality pattern (Fig. 2).
stability forms an important criteria
management can be applied to
Customer / Market Requirements whilst bioavailabilty, potency and
improve and sustain the quality of
reactivity of trace minerals aid in
premix. Modern quality Production plan Specifications for
RM requirement plan Raw Materials
their selection process. The form of
management has three interrelated
ingredient selected must also be
elements i.e. quality design, quality Purchase of raw materials
easily available, of economic
control and quality improvement
Receipt of Materials interest and also impart acceptable
(Fig. 1).
physical attributes to the premix.
•Vitamins
Quality Design •Trace minerals In order to maintain the stability
(Customer requirements) •Medicaments of vitamins throughout their shelf
•Supplements & additives
•Carriers & diluents life it is recommended to procure
Q.C Sampling & more stable derivatives like coated
Analysis
forms, that are not destroyed even
Approved Rejected
Approved material when mixed with trace minerals.
Back to supplier
for processing The spray-dried form of vitamins
Formulation
improves the flowability of the
Quality Improvement Quality Control
(Problem (Evaluation premix. The list of nutrients with
Identification against Weighing
& rectification) Standards) their recommended sources is
Fig 1. Quality management shown in Table 1.
Mixing Q.C Sampling
In premix production & analysis The specifications for all raw
A quality premix can be Labeling & Packaging materials should be based on
manufactured only through a Storage Accep
ted
Rejected
recommendations applicable for
stringent quality assurance particular animal's feed as
Dispatch Processing
programme and current good mentioned by AAFCO, AOAC,
manufacturing practices (cGMP). Fig 2: Flow chart of premix
production process AFMA, I.P, U.S.P., etc.
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Table 1 : Nutrients and its sources The storage area for approved and
Nutrient Sources rejected materials must be distinct
Iron Ferrous sulphate monohydrate in order to prevent any confusion.
Ferrous carbonate 4. Sampling & Analysis
Copper Copper sulphate pentahydrate
Sampling of raw materials is
Tribasic copper chloride
performed following a quality
Zinc Zinc oxide,
Zinc sulphate assurance programme. To obtain a
Manganese Manganese oxide, representative sample, sampling
Manganese sulphate should be done from bottom, center
Magnesium Magnesium oxide and top layer of the bag using a
Iodine Calcium iodate , Potassium iodate sample probe. When large
Cobalt Cobalt carbonate consignments of raw materials are
Molybdenum Sodium molybdate received, it is advisable to mix the
Selenium Sodium selenite raw material in mixer and then
Vitamin A Retinyl acetate (C) analyze each mixed batch to make
Vitamin D3 Cholecalciferol (C)
an accurate assessment.
Vitamin E dl-α-tocopherol acetate (S.D.)
Instruments like H.P.L.C, flame
Vitamin B1 Thiamine mononitrate (P)
Vitamin B2 Riboflavin (S.D.) photometer and spectrophotometer
Vitamin B3 Niacin (P) are used for analysis of raw
Vitamin B5 D-calcium pantothenate (P) materials to obtain accurate results.
Vitamin B6 Pyridoxine HCL (P) Raw materials should be analyzed
Vitamin B12 Cyanocobalamin (1%) using official methods by trained
Vitamin Biotin Biotin (2%) personnel.
Vitamin Folic acid Folic acid (S.D.) Approved raw materials may be
Vitamin K 3 Menadione Nicotinamide Bisulphite-MNB or considered for formulation. If raw
Menadione Sodium Bisulphite-MSB (C) materials are differing in their
S.D.- spray dried, P-pure, C-coated particle size but other parameters
2. Purchase of Raw Materials by using electronic balance. The are satisfactory then they should be
Raw materials must be complete details of the raw material considered for further processing
procured from approved vendors along with its reference number like sieving, milling etc. When they
and should conform to the must be entered into the stock are not meeting the pre-determined
specifications laid down by the records. specifications in terms of potency or
nutritionist. No material should be The raw materials should be purity then they should be rejected.
received without a certificate of logged in after segregation of drugs 5. Processing
analysis. and other nutrients. Extra care must Processing seeks to modify the
Purchases should be done be taken for labeling. Bags or physical properties of raw materials
periodically taking care that containers must be stored in a dry to meet the specifications of premix.
sufficient inventory is maintained at location on pallets assigned to them Processing basically includes:
all times. A purchase plan is taking care of sufficient space (A) Sieving
desirable in accordance with between the pallets for comfort (B) Milling
production requirement. Sieving is a primary process of
loading and unloading. To prevent
3. Receipt & Storage of Raw development of stacking resistance removing foreign materials from raw
Materials not more than 10 bags are to be materials as well as separating
stored on one pallet. Meanwhile coarse ingredients. The operation
The receiver should have
stacked stocks should be rotated to can be carried out in equipments
enough information from the quality
minimize lump formation, product like vibratory or mechanical sifters.
assurance program to be able to
degradation, and insect infestation. Care must be taken that the sifter is
recognize the quality of product.
cleaned well before and after use to
Sacked ingredients should be The storage area must have
prevent any sort of contamination.
checked for identification and sufficient protection from rodents
The 'overs' obtained in the sieving
condition. A reference number and insects. It should be well
process may then be ground.
should be allotted for each raw ventilated, sanitized and away from
A multimill can be used to
material received into the premises. direct sunlight. Depending on the
reduce particle size to the desired
The sacked ingredients must then stability of raw material they must be
screen analysis. Regular checks
bear this reference number. Large stored in environment of controlled should be performed to detect wear
consignments are to be weighed at temperature and humidity. of mill screen and blades.
weigh bridge whereas small ones
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The sieved and milled material is Chemical Characteristics Better premixes can often be
then bagged, weighed, labeled and Potency of vitamins, trace prepared by employing a blend of
transferred to the warehouse area minerals and medicaments need to predetermined ratio of several
for storage. be considered whilst formulating diluents rather than with just one.
high quality premixes. Based on the The organic carrier absorbs
B. FORMULATION
customer's requirement the moisture while inorganic carrier
This is an important and critical step formulator has to include the contributes towards density of
in manufacturing a premix. micronutrients considering their premix.
Qualified personnel possessing analytical value so that desired The formulator has to consider
knowledge and expertise regarding amount can be delivered when all the above-mentioned
micro ingredients and powder mixed in the feed. No materials parameters whilst preparing the
technology should formulate a should be incorporated in the batch control or manufacturing
premix. premix without analysis since under record. The batch manufacturing
The formulator has to consider or over addition may have record serves as a link between the
source of ingredients based on their deleterious effect on the overall formulator and actual production.
physical, chemical characteristics, performance of the birds consuming While preparing the batch sheet the
bioavailability, their interactions the feed. formulator has to give importance
when mixed, handling Selection of carrier and its for the following details:
characteristics, and economic percentage is important for
implications on the final product formulating a quality premix. It is • Nutrient requirements
before any final conclusion is generally preferable to leave • Selection of ingredients
arrived at. sufficient space for a carrier in order • Potency of ingredient
Table 2 : Physico-chemical to minimize any sort of interactions • Process loss
characteristics of raw materials between the active ingredients. The
Physical Chemical • Level of free flowing agents
carrier should serve the functions as
Characteristics Characteristics • Level of antioxidant
depicted below:
• Percentage of carrier
Particle size Potency • It should neutralize the
• Packing & packaging material
Particle shape Purity electrostatic charges present in
Particle density pH • Inventory of materials
certain ingredients.
The manufacturing of a premix
Flowability Reactivity • Chemically inert
Compressibility Stability should follow the batch control
• Primarily have the density,
sheet under the supervision of
Physical Characteristics particle shape and particle size
trained personnel. The batch sheet
Particles of uniform size, compatible with other micro
should comprise following details:
density and that of spherical shape ingredients so as to prevent any
• Name of the premix
blend well to form a homogenous demixing in the premix.
• Code of premix
mixture. The chance of segregation • Water sequester from other raw
is thereby minimized. For example • Production date
materials thereby reducing water
trace minerals available in the activity and improve stability of • Batch no. of premix
market are invariably found to be the premix. • Batch size
coarse in nature whereas the • Impart good flowability. • List of ingredients to be mixed
vitamins are normally fine powders. Types of carrier widely used in the • Batch no. of ingredients to be
Achieving a homogenous mixing of formulation of premix: mixed
these two ingredients would be (A) Organic carriers • Mixing order of ingredients
difficult (sand and pebble effect). (B) Inorganic carriers • Actual quantity of ingredients to
However, homogenous mixing can be taken
Table 3: List of carriers
be achieved by processing the trace used in premix • Mixer name and mixing time
minerals to the desired particle size Organic Inorganic • Instructions regarding packing
and improved flowability. Carriers Carriers and mixing
The flowability of the Wheat Calcium
• Provision for signatures
ingredients plays a vital role while middling carbonate
All the above-mentioned details aid
handling the powder i.e. before and Rice hulls Dicalcium
in keeping a track of the premix
after mixing. Poor flowability results Phosphate
which may be traced in future with
in bridiging, caking and product loss Corn cobb, Monocalcium
ground phosphate respect to customer complaints or
in the transfer system. Conversely
Soya bean meal Zeolite product recall. Thus it serves as a
too fluid a product may cause
Lactose Fine dried salt control copy.
flushing.
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C. WEIGHING D. MIXING A normal feed mixer is not
recommended for premixes. A
Weighing is an important point in The mixing process is the heart of
specialized mixer capable of mixing
manufacturing of a premix. No any premix-manufacturing unit. In a
to a low CV (Coefficient of variation)
matter how good the formula is, it is premix the proportion of ingredients
is the most desired. Specialized
difficult to achieve the desired vary considerably; hence in order to
Nauta mixers are normally capable
obtain a homogenous blend the
nutrient levels in the premix without of ensuring homogenous mixing.
mixing operation should be divided
precise weighing. Any extra Examples of mixers: ribbon
into two steps
addition of vitamins may not mixer, conical screw mixer, mass
A) Micro mixing
improve performance but costs mixer, and cylindrical plough mixer
B) Macro mixing
extra money, whereas lower levels etc.
A) Micro mixing, as the name
could depress performance. suggests, is for mixing micro (ii) Mixing time
Precision in weighing is critical for ingredients which weigh less The mixing time is also crucial for
certain ingredients like Selenium, than one percent of mixer obtaining a homogenous premix. It
and Roxarsone where mistakes capacity. These ingredients is evident that shorter mixing time
may even prove toxic. should be initially mixed in a leads to under mixing while
The accuracy of the weighing smaller capacity mixer like prolonged mixing time results in
balance enables precise weighing. double cone blender. The demixing. By trial and error and also
micro mix so obtained should by conducting coefficient of
The accuracy decreases with
be then mixed in the large variation studies, optimum-mixing
increasing size of the scale. As a
mixer with all other time can be arrived for a particular
general rule, a scale is accurate to
ingredients. mixer.
no more than 0.1% of its total B) Macro mixing is the actual
capacity. There is large variation in (iii) Mixing order
blending of all components of
doses of different micro ingredients the premix along with carriers The sequence of addition of various
added in the premix. So weighing in a batch mixer .The content ingredients while loading the mixer
balances need to be sized uniformity of the premix is can affect the quality of premix. If
according to their use as depicted based on following proper mixer loading sequence is
below: parameters: not followed, oil balls, chemical
(i) Type of Mixer interactions and particle
Table 4 : Selection of scales as a (ii) Mixing Time segregation can result in a premix.
function of product (iii) Mixing order
Do's Don'ts
(i) Type of mixer Clean the mixer Collection of first few
Ingredients Range of Precision before and after use. bags after mixing
scale (kg) (g) A mixer selected must be able to
Vitamins A, D3, provide homogenous mixtures of Area must be Collection of premix
E, Niacin, Cal pan 300 to 1 100 free of remains in unlabeled bag
Trace minerals physically adverse particles of previous batch
incorporated at various levels in the
Vitamins B, K Addition of Collection of premix
Cobalt, Iodine, 20 to 0.5 20 mix. Horizontal or vertical mixers
Ingredients when the mixer is on.
Molybdenum, can be used. It must meet safety when the mixer
Selenium standards and must be properly is on
Amino acids installed. The requirements of a Note the mixing Collection of premix
Minerals 1000 to 100 1000 start and end time before the specified
Carriers mixer are:
mixing time
• Affords good homogeneity with
the component included at Strict adherence Addition of reactive
Assurance in weighing can be lowest possible content.
to the mixing order materials in the
beginning.
achieved by calibrating balances • Short mixing time
against standard weights. The • Variable degree of filling, with no Regular mixer evaluation should be
balances should be preferably loss of mixing efficiency. accomplished by conducting co-
calibrated daily in the beginning of • Complete emptying efficient of variation studies. C.V
weighing and documented • Easy Cleaning value of less than 5% is indicative of
accordingly. They should be • Provision for adding liquids excellent mixing. The mean assay
cleaned before and after use and • Absence of heat during mixing value for the tracer should also be
• Provision to break the lumps within the permissible limits of
must be subjected for maintenance
• Less consumption of energy analytical variation. Any deviation
twice a year.
• Least maintenance cost from the expected result indicates
• Cost effective any one of the following:
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• Improper mixing time should bear labels of different • Make separate provision for
• Irregular mixing order colour. This prevents any storing sale return or expired
• Selection of bad mixer confusion and mix-ups premix
• Improper alignment of mixing between the premixes. • Keep floors, walls and
aids A premix label should have walkways clean, dry and free of
• Wear out of internal part
following information: any obstructions.
• Larger analytical variations
indicative of poor lab analysis • Name of the premix • Place sinks and bathrooms
Lack of uniformity in a premix is • Composition away from premix storage area.
compounded when mixed into • Dosage of premix • Keep the area free from pests
finished feed (multiplier effect). and rodents
• Net weight of premix contained
Hence utmost care has to be taken • No bag should be stored
in the package (in kg)
whilst manufacturing a premix. without any label.
• Regulatory/Statuatory
E. PACKAGING When stored under such conditions
statements. the consumer is guaranteed of its
The primary purpose of packaging • Date of manufacture in label claim.
for premix is to maintain the stability month/year
of micronutrients and to protect the METHODS OF QUALITY
• Date of expiry in month/year CONTROL
integrity of the premix. Improperly
packaged premixes experience • Batch number
1. For raw materials
considerable loss in the potency of • Storage conditions 2. For production process
various sensitive ingredients. • Directions for use 3. For finished premix
Selection or designing of • Name and address of the 1. The raw materials must be
packaging material should be manufacturer with logo analysed first and only then
according to the local climatic
• Disclaimer note if any incorporated in the premix once it
conditions. It should bear following
Careful attention must be paid while meets all the specifications. The
properties:
preparing label since the customer formulator must be strict while
• Provides barrier against light,
follows the instructions given on the considering the nutrient percentage
moisture, oxygen
label. Any mistake made will be in the raw material. Proper
• No chemical interactions with
carried on to the feed and ultimately segregation must be done for the
the premix
affect the performance of the birds. approved and rejected materials.
• Provides good printing surface
G. STORAGE Care should be exercised while
• Sturdy enough to withstand the
actually taking the material for
transport pressure. The quality of premix is also production. The raw material must
The different types of affected by the storage conditions in be sieved to omit any foreign and
packaging materials that could be the premises until it is transported oversized material, if necessary
use are glass containers, aluminium through distribution channels. process before use.
foil, paper and plastics. Ideally, The following steps are 2. T h e P r e m i x p r o d u c t i o n
aluminium foil lined multilayered recommended during warehouse process ensures the precise
paper bags provides an excellent storage: weighing & inclusion of each
barrier against light, moisture,
• The temperature and humidity required micro-ingredient in the
oxygen, odour and flavour. Hence
of warehouse should be premix. This method must be fool
for very sensitive ingredients and
controlled below critical levels. proof and verifiable through a
where cost is not a constraint,
• Keep the area clean, well lit and system of physical (weight) and
aluminium foil package is the
ventilated with fresh air. book (record) checks.
material of choice.
A preinclusion check should be
• Store the premix on the pallet
F. LABELING performed by quality assurance
meant for it taking care not to
Labeling of premix serves two personnel whereby random check
store more than 10 bags on is made for the number of bags,
purposes:
each pallet.
• Provides complete information quality of material, their weights,
about the premix • Design the storage areas to cleanliness of mixer, integrity of
• Gives an identity to the premix facilitate the FIFO (First in First packaging material and labeling. If
and helps in differentiating from Out) policy, with bags stored in any deviation is observed corrective
other premixes. The premixes consecutive order so that oldest steps should be taken immediately
for different segments like layer, can be withdrawn first. so that the error is not carried on to
broiler, breeder and dairy the final product.
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A post manufacturing check is of type of premix that would not Monitoring of all the critical points
necessary to assure that premix be affected by a low level of a affecting the quality of premix is
manufactured is free of lumps and contamination. the best solution for minimizing
freely flowable. c) Mixer cleanout procedures-The the deviations from standards.
Cross contamination should be mixer must be cleaned It is only through well-
eliminated while manufacturing thoroughly before and after use organized, adequately staffed
quality premix. It becomes a matter with brush and compressed air. and accurately performed
of concern when drugs get carried A thorough wash out process and formulation controls
over from one premix to another that programme must be performed that a desired quality of the premix
is meant for another segment and at least once a week. Care may be achieved.
where the contaminated drug is should be taken to ensure that
toxic to other species. There are the mixer is clean and dry before References:
three main methods that can reduce use. 1. P. Raven & G. Walker. Food
cross contamination in premix: 3. The quality of finished premix is and Agricultural Organization
assured by analysing the same in of United Nations, 1980.
a) Flushing- This is a technique
the laboratory .The premix must be 2. A. J. Leslie. Quality control in
whereby an ingredient such as
analysed for physico-chemical feed milling, procedures for an
ground grain or any carrier
properties. The premix should be effective program, ASA.
material is run through the
dispatched only if all the parameters 3. D. Monsalve. Key points in
system after a batch of
are satisfactory. It may be difficult to mixing and delivery of micro
medicated premix is produced.
analyse each and every batch ingredients in Feed
This ingredient will pick up
manufactured for complete analysis Formulations.
much of the contamination in
and hence a sampling plan must be 4. Micro ingredient Premixing,
the system and then must be
designed mentioning the analysis Keeping Current. BASF
bagged up and used later when
frequency of such premixes. Corporation.
premix containing the same
Premix is a critical input in 5. Quality assurance as applied
medicament is made.
feeds. The use of a quality premix is to micronutrient fortification.
b) Sequencing-This technique an important feature in any livestock Guidelines for technicians,
involves the production of feeds operation leading to improved supervisors and workers
containing the same medication safety, reliability and performance. concerned with Nutition. Eds P.
at the same time. This reduces The production of quality premix Nestel, R. Nalubola, and E.
the number of times thus deserves careful and Mayfield.(ILSI)
contamination may occur. A run professional attention. Product 6. D. Armstrong and K. Behnke.
of the medicated premix would quality must be built into and not Premixing MF-2056, Dept. of
then be followed by production merely tested in, the product. Grain Science and Industry.

(An ISO 9001 : 2000 Company)

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Phone.: + 91-124 - 4011147, 2347548, Fax : + 91-124 - 4013620
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