Annex I - Terms of Reference for Laboratory Services 1. Background As part of the procurement process, random sampling and testing of purchased products should be carried out in order to ensure that a product complies with its technical specifications. Different types of testing may be necessary for the various commodity groups. UNICEF Supply Division (SD) does not have a quality control laboratory performing chemical, microbiological and sterility testing of the purchased products. Consequently, SD contracts with external laboratory services in the following commodity areas: Pharmaceutical products Nutrition products (Mainly Therapeutic and Supplementary Food) Bednets (Insecticide level) A pharmaceutical product is generally tested either against its compendial specifications [i.e. The International Pharmacopoeia (Ph. Int.), The British Pharmacopoeia (BP), The United States Pharmacopoeia (USP)] or against its in-house approved specifications. Testing of nutrition products consists principally of safety-driven microbiological testing and quantitative compliance. Microbiological testing ensures absence of pathogenic microorganisms while quantitative testing assesses the specified composition in relation to nutrition values (e.g., proteins and fat) and micronutrient levels for vitamins and minerals. Chemical testing of bednets focuses on qualitative and quantitative analysis of the embedded insecticide. A sampling and testing plan for pharmaceutical and nutrition products is elaborated on an annual basis. WHO pre-qualified laboratories have been used for quality control testing of pharmaceutical products and bednets. An independent laboratory has been used for microbiological testing of nutrition products. 2. Objectives, Purpose & Expected results It is expected that 50 – 100 batches of pharmaceuticals will be tested annually against their approved specifications while 20 – 30 tests of nutrition products in relation to their compliance with nutrition values will be carried out. It is estimated that due to introduction of the expanded microbiological testing of nutrition products,1000-2000 tests will be performed per year. It is projected that the number of insecticide content tests on Bednets will be 50-100. Further to sterility testing of pharmaceuticals a limited number of sterility testing on certain medical devices will also be performed. Due to an increase in testing of nutrition products for Salmonella and Enterobacteriacea, and possibly follow-up testing for presence of C. Sakazakii, it is important for laboratories to have sufficient capacity for microbiological testing. It is also crucial for laboratories to have the ability to perform all the requested analyses in a timely manner and promptly deliver analytical results. UNICEF country offices may also use the same laboratories for testing of locally manufactured nutrition products (e.g. RUTF). Therefore laboratories must be able to invoice different UNICEF offices, but at the same time the results of the analyses must be shared with both the requested country office as well as UNICEF SD Quality Assurance in order to keep oversight of the testing carried out.
Transcript
Annex I - Terms of Reference for Laboratory Services
1. Background
As part of the procurement process, random sampling and testing of purchased products should be
carried out in order to ensure that a product complies with its technical specifications. Different types
of testing may be necessary for the various commodity groups. UNICEF Supply Division (SD) does not
have a quality control laboratory performing chemical, microbiological and sterility testing of the
purchased products. Consequently, SD contracts with external laboratory services in the following
commodity areas:
Pharmaceutical products
Nutrition products (Mainly Therapeutic and Supplementary Food)
Bednets (Insecticide level)
A pharmaceutical product is generally tested either against its compendial specifications [i.e. The
International Pharmacopoeia (Ph. Int.), The British Pharmacopoeia (BP), The United States
Pharmacopoeia (USP)] or against its in-house approved specifications. Testing of nutrition products
consists principally of safety-driven microbiological testing and quantitative compliance.
Microbiological testing ensures absence of pathogenic microorganisms while quantitative testing
assesses the specified composition in relation to nutrition values (e.g., proteins and fat) and
micronutrient levels for vitamins and minerals. Chemical testing of bednets focuses on qualitative and
quantitative analysis of the embedded insecticide.
A sampling and testing plan for pharmaceutical and nutrition products is elaborated on an annual
basis. WHO pre-qualified laboratories have been used for quality control testing of pharmaceutical
products and bednets. An independent laboratory has been used for microbiological testing of
nutrition products.
2. Objectives, Purpose & Expected results
It is expected that 50 – 100 batches of pharmaceuticals will be tested annually against their approved specifications while 20 – 30 tests of nutrition products in relation to their compliance with nutrition values will be carried out. It is estimated that due to introduction of the expanded microbiological testing of nutrition products,1000-2000 tests will be performed per year. It is projected that the number of insecticide content tests on Bednets will be 50-100. Further to sterility testing of pharmaceuticals a limited number of sterility testing on certain medical devices will also be performed.
Due to an increase in testing of nutrition products for Salmonella and Enterobacteriacea, and possibly follow-up testing for presence of C. Sakazakii, it is important for laboratories to have sufficient capacity for microbiological testing. It is also crucial for laboratories to have the ability to perform all the requested analyses in a timely manner and promptly deliver analytical results. UNICEF country offices may also use the same laboratories for testing of locally manufactured nutrition products (e.g. RUTF). Therefore laboratories must be able to invoice different UNICEF offices, but at the same time the results of the analyses must be shared with both the requested country office as well as UNICEF SD Quality Assurance in order to keep oversight of the testing carried out.
3. Description of the assignment
Lot I - Pharmaceuticals – Bednets – Medical Devices (sterility)
Analytical testing for pharmaceuticals will be performed against compendial specifications [i.e. The
International Pharmacopoeia (Ph. Int.), The British Pharmacopoeia (BP), The United States
Pharmacopoeia (USP)] or against approved in-house specifications. The analytical testing for Bednets
is limited to an HPLC method measuring insecticide concentration. Sterility testing of pharmaceutical
products and medical devices should take place in accordance with compendial methods.
The list of pharmaceutical products to be tested in 2014 are provided on the below table. Full testing
according to the relevant Pharmacopoeial monographs ([i.e. The International Pharmacopoeia (Ph.
Int.), The British Pharmacopoeia (BP), The United States Pharmacopoeia (USP)] or the approved in-
house specifications should be performed
Artemeth20mg+lumefan120mgtabs/24/PAC-30 Amoxici.pdr/oral sus 125mg/5ml/BOT-100ml
17 Mesophyllic aerobic bacteria 10,000 cfu per g (maximum)
ICC No 125 AACC 42-11
18 Coliforms 10 cfu per g (maximum)
AOAC 2005.03
19 Salmonella 0 cfu per 25g AACC 42-25B
20 Escherichia Coli 0 cfu per g AOAC 991.14
21 Staphylococcus aureus 0 cfu per g AACC 42-30B
22 Bacillus cereus 50 cfu per g (maximum)
AOAC 980.31
23 Yeasts and moulds 100 cfu per g (maximum)
ICC No 146 AACC 42-50
24 GMO (Only if required) Negative (< 0.9% of GMO material)
4. Deliverables
Chemical and microbiological test results on pharmaceuticals should be provided within two weeks of sample receipt. In case of individual specification testing, results should be provided within one week of sample receipt.
Sterility test results for pharmaceuticals and medical devices should be provided within 3 weeks of sample receipt.
Insecticide content results for bednets should be provided within one week of sample receipt
Results on nutritional composition (e.g. protein, lipids, vitamins, minerals) should be provided within two weeks of sample receipt. In case of individual specification testing, results should be provided within one week of sample receipt.
Microbiological test results on nutrition products should be provided within one week of sample
receipt. Tests for C. sakazakii, will be carried out when the EB results are higher than the specification
allows and test results should be provided within one week.
Test results on Aflatoxins should be provided within two weeks of sample receipt.
5. Reporting requirements
Test results should be provided in English in the form of a report where at least the following information should be included:
Header Section: Name, address and contact details of the laboratory conducting the analysis
General Information Section: Name of product, dosage form, name of manufacturer, lot/ batch number, manufacturing date, expiry date, purchase order (if applicable)
Analysis Section: The test name, the result, the acceptance criteria or specifications, and a reference to the test method used should be included for each characteristic listed. Actual data and observations should be recorded rather than non-specific “passes” or “conforms” statements.
Footer section: Identity and signature of authorized individual for approval, date of approval, page number (i.e 1of 3)
The report should be sent electronically in PDF format to UNICEF SD Quality Assurance Centre. A hard copy of the report accompanied by the invoice should be send to UNICEF country office or to UNICEF SD Quality Assurance Centre. In case of “out of specification results” the subject line of the Email and the report should state “Alert OOS results”
6. Duration of the LTAS
It is expected that 24 month Long Term Arrangements with possible extension for further 12 months will be put in place in September or October 2014.
UNICEF will establish LTAS with 2 laboratories for composition and microbiological testing of nutrition
products and 2 laboratories for pharmaceutical, sterility and insecticide level (bednets) testing.
7. Response from Bidders:
The Technical Proposal should include but not limited to the following:
- Detailed Methodology/Approach to project, demonstrating how you meet or exceed UNICEF
requirements for this assignment.
- An overview of the Quality system in place should be provided including details on:
- Receipt of Samples
- Processing of Samples
- Storage of Samples
- Disposal of Samples
- ISO or WHO certification as detailed in section 8 (Qualification requirements)
- Expertise of Company detailing the general and specific experience similar assignments in
the past five years. More specifically evidence of similar assignment implemented in the past
Evidence could be in form of job completion certificate, contracts and or references. The
submission should also include list of five similar assignment in terms of requirements and
scope implemented in the past 5 years. Please provide the following:
- Name of Client
- Title of the Project
- Scope of the Project/Requirements
- Proposed Solution/Outcome
- Project timelines (start and end date year, etc., and any other information
necessary)
- Reference /Contact person with the reference
- Detailed resume of the person responsible for the laboratory and the person in charge of the
project , if different
Number of personnel to be involved in the project and educational qualifications/ professional
experiences
Note: Bidders must bid for at least 1 complete lot or bid for both 2 lots based on their capacity,
partial bid per lot shall be disqualified.
8. Qualification requirements
Laboratories conducting tests on pharmaceuticals, bednets and medical devices (sterility) should be WHO pre-qualified
They should also operate according to WHO Technical Report Series No. 902, 36th report, 2002 – Annex 3 “Good practices for national pharmaceutical control laboratories.
Laboratories performing tests on nutrition products must be ISO 17025 certified and accredited to perform testing for Salmonella (ISO 6579), Enterobacteriaceae (ISO 6579) and C. Sakazakii (ISO 22964)
Laboratories should have a proven record of working with UN organisations or international organization such as e.g. WHO, WFP or the Global Fund.
9. Evaluation Process and Methods
Proposals meeting the mandatory criteria specified above and in Annex II will continue into the
evaluation of the technical proposals. In assessing each proposal, UNICEF values technical factors
more than cost factors. This will be reflected in the weighting that UNICEF will employ in assigning a
total score to each proposal. While the technical score will be significantly more important, cost will
remain a factor in the evaluation. The ratio Technical/Cost will be 70/30. The score assigned to each
proposal will be of guidance in determining which proposal would provide the greatest value to
UNICEF.
Proposals received in response to this Request for Proposals will be evaluated on the basis of the
following technical criteria per lot.
s/no Technical Evaluation Criteria Points
Technical Approach
1 Proposals will be assessed on the extent to which the proposed approach and
methodology are solid, feasible, implementable, and effective and
demonstrate a clear understanding of the nature of the work being undertaken
and the environment in which the work must be performed. The proposed
work plan must also describe that there will be no issue with custom clearance
of samples submitted. The lead time for analysis must be specified in the
proposal and meet the above stated deadlines. The laboratory must also
demonstrate that they have a sufficient capacity to deal with the anticipated
number of analysis in a timely way. ISO and WHO Certification.
40 points
2 Expertise of the Personnel and Organization - Proposals will assess the extent
to which the laboratory has sufficient personnel with the necessary education,
training, technical knowledge and experience for their assigned functions.
10 points
a The Head of the Laboratory (supervisor) must be of a high professional standing
with extensive experience in drug analysis and laboratory management in a
pharmaceutical control laboratory in the regulatory sector or in the industry.
b The analysts, who must be graduates in pharmacy, analytical chemistry,
microbiology or other relevant subjects with the requisite knowledge, skills and
ability to adequately perform the tasks assigned to them by management and
to supervise technical staff. Personnel should have the minimum qualification
and experience as mentioned.
3 Organizational Capabilities and Past Performance 20 points
Organizational Capabilities and Past Performance Proposals will be assessed
based on the extent to which the Proposer’s corporate and institutional
capability demonstrates an ability to successfully and quickly launch and
implement the Terms of Reference.
Overall total points for technical evaluation 70 points
Only Submissions that scores 50 points and above shall be considered
further for commercial proposal evaluation
Commercial Evaluation: The overall total for each lot shall be used for the commercial evaluation of
all technically compliant bidders. The commercial evaluation shall be done as shown below:
The price should be broken down for each component of the proposed work, based on an estimate of time taken which needs to be stated (see Annex III). The total amount of points allocated for the price component is 30. The maximum number of points will be allotted to the lowest price proposal per lot that is opened and compared among those invited firms/institutions which obtain the threshold points in the evaluation of the technical component. All other price proposals will receive points in inverse proportion to the lowest price; e.g.:
Max. Score for price proposal * Price of lowest priced proposal
Score for price proposal X = ---------------------------------------------------------------------------
Price of proposal X
The proposal obtaining the overall highest score after adding the scores for the technical and financial proposals is the proposal that offers best value for money.
Note: For the purpose of evaluation, UNICEF shall use US Dollars to evaluate all commercial
proposals. All proposals submitted in any other currency shall be converted to US Dollars using the
prevailing UN exchange rate at the time of evaluation. Contracts shall be issued in the currency of
the bids submitted by the selected supplier(s).
UNICEF shall enter into LTAS with the bidder(s) that is/are the most responsive per lot(s)
UNICEF will establish LTAS with 2 laboratories for composition and microbiological testing of nutrition
products and 2 laboratories for pharmaceutical, sterility and insecticide level (bednets) testing. For
specific requests, orders shall be placed based on the following considerations:
i. Price
ii. Availability of capacity to implement the assignment
iii. Geographical location
10. Administrative issues – Payment Schedule
Laboratories are requested to provide price quotes for individual parameter testing as well as for comprehensive testing. Payments will be issued 30 days after receipt of the invoice and satisfactory validation of the test report.
Annex II: Test Turnaround Time Compliance form
s/no Type of Test Turnaround
time for result
Compliance
(YES/NO)
Comments
Chemical and microbiological test results
on pharmaceuticals
2 weeks
individual specification testing for
Chemical and microbiological test results
on pharmaceuticals
1 week
Sterility test results for pharmaceuticals
and medical devices
3 weeks
Insecticide content results for bednets 1 week
nutritional composition (e.g. protein,
lipids, vitamins, minerals)
2 weeks
individual specification testing 1 week
Microbiological test results on nutrition
products
1 week
Tests for C. sakazakii, will be carried out
when the EB results are higher than the
specification allows
1 week
Aflatoxins 2 Weeks
Notification of OOS results Depending on
the
turnaround
time for the
above
mentioned
tests
*Note: This table is to be completed, signed and submitted alongside the Technical Proposal
Annex III – Laboratory Qualification Compliance form
1 Is your Laboratory WHO Prequalified to conduct tests on pharmaceuticals according to WHO Technical Report Series No.961, 2011- Annex 12?
Please provide
document evidence
2 Is your Laboratory operating according to WHO Technical Report Series No. 902, 36th report, 2002 – Annex 3 “Good practices for national pharmaceutical control laboratories?
Please provide
document evidence
3 Is your Laboratory ISO 17025 certified and accredited to perform testing for Salmonella (ISO 6579), Enterobacteriaceae (ISO 6579) and C. Sakazakii (ISO 22964)?
Please provide
document evidence
4 Does your laboratory have proven experience working with UN organizations or international organization such as e.g. WHO, WFP or the Global Fund?
Please provide
document evidence.
Evidence could be
past contract or
completion
certificates e.t.c.
*Note: This table is to be completed, signed and submitted alongside the Technical Proposal
Annex IV – Technical Evaluation Table
Lot 1 - (Pharmaceuticals, Bednets & Medical Devices)
s/no Technical Evaluation Criteria Points
Technical Approach
1 Proposals will be assessed on the extent to which the proposed approach and
methodology are solid, feasible, implementable, and effective and
demonstrate a clear understanding of the nature of the work being undertaken
and the environment in which the work must be performed. The proposed
work plan must also describe that there will be no issue with custom clearance
of samples submitted. The lead time for analysis must be specified in the
proposal and meet the above stated deadlines. The laboratory must also
demonstrate that they have a sufficient capacity to deal with the anticipated
number of analysis in a timely way. ISO and WHO Certification. Quality
Assurance and risk mitigation put in place.
40 points
2 Expertise of the Personnel and Organization - Proposals will assess the extent
to which the laboratory has sufficient personnel with the necessary education,
training, technical knowledge and experience for their assigned functions.
10 points
a The Head of the Laboratory (supervisor) must be of a high professional standing
with extensive experience in drug analysis and laboratory management in a
pharmaceutical control laboratory in the regulatory sector or in the industry.
b The analysts, who must be graduates in pharmacy, analytical chemistry,
microbiology or other relevant subjects with the requisite knowledge, skills and
ability to adequately perform the tasks assigned to them by management and
to supervise technical staff. Personnel should have the minimum qualification
and experience as mentioned.
3 Organizational Capabilities and Past Performance 20 points
Organizational Capabilities and Past Performance Proposals will be assessed
based on the extent to which the Proposer’s corporate and institutional
capability demonstrates an ability to successfully and quickly launch and
implement the Terms of Reference.
Overall total points for technical evaluation 70 points
Only Submissions that scores 50 points and above shall be considered
further for commercial proposal evaluation
Annex IV – Technical Evaluation Table
Lot 2 - (Ready to use Therapeutic Foods (RUTF)
s/no Technical Evaluation Criteria Points
Technical Approach
1 Proposals will be assessed on the extent to which the proposed approach and
methodology are solid, feasible, implementable, and effective and
demonstrate a clear understanding of the nature of the work being
undertaken and the environment in which the work must be performed. The
proposed work plan must also describe that there will be no issue with
custom clearance of samples submitted. The lead time for analysis must be
specified in the proposal and meet the above stated deadlines. The
laboratory must also demonstrate that they have a sufficient capacity to deal
with the anticipated number of analysis in a timely way. ISO Certification.
Quality Assurance and risk mitigation put in place.
40 points
2 Expertise of the Personnel and Organization - Proposals will assess the extent
to which the laboratory has sufficient personnel with the necessary
education, training, technical knowledge and experience for their assigned
functions.
10 points
a The Head of the Laboratory (supervisor) must be of a high professional
standing with extensive experience in drug analysis and laboratory
management in a pharmaceutical control laboratory in the regulatory sector
or in the industry.
b The analysts, who must be graduates in pharmacy, analytical chemistry,
microbiology or other relevant subjects with the requisite knowledge, skills
and ability to adequately perform the tasks assigned to them by management
and to supervise technical staff. Personnel should have the minimum
qualification and experience as mentioned.
3 Organizational Capabilities and Past Performance 20 points
Organizational Capabilities and Past Performance Proposals will be assessed
based on the extent to which the Proposer’s corporate and institutional
capability demonstrates an ability to successfully and quickly launch and
implement the Terms of Reference.
Overall total points for technical evaluation 70 points
Only Submissions that scores 50 points and above shall be considered
further for commercial proposal evaluation
Annex V - Commercial Proposal Table
Lot 1 - (Pharmaceuticals, Bednets & Medical Devices) - Please provide the currency of
your bid
s/no Type of Test Estimated
number of
test/annum
Unit
Price
Total
Price
1 Pharmaceuticals Pharmacopoeial Monograph or approved in-house specifications (average price for full testing against the pharmacopoeial monograph should be provided)
100
2 Bednets Assay- insecticide concentration
50
3 Medical Devices Sterility testing (compendial method)
20
Total
Note: Please note that the number of test per annum is only an estimate and the actual number of
test per annum may vary during the contract period.
Note: For the purpose of evaluation, UNICEF shall use US Dollars to evaluate all commercial
proposals. All proposals submitted in any other currency shall be converted to US Dollars using the
prevailing UN exchange rate at the time of evaluation. Contracts shall be issued in the currency of
the bids submitted by the selected supplier(s).
Annex V - Commercial Proposal Table
Lot 2 - (Ready to use Therapeutic Foods (RUTF) - Please provide the currency of your bid
s/no Type of Test Estimated
number of
test/annum
Unit
Price
Total
Price
1 Ready to Use Therapeutic Foods (RUTF)
Nutritional composition per 100 g of RUTF paste
Moisture content 2.5% maximum
Water activity 0.6 maximum
Energy 520-550 kcal
Proteins 10-12% total energy
12.8-16.2% by weight
Lipids 45-60% total energy
25.8-36.3% by weight
n-6 fatty acids 3-10% total energy
n-3 fatty acids 0.3-2.5% total energy
Trans-fatty acids <3% total fat
Fibre <5%
Sodium 290 mg maximum
Potassium 1100-1400 mg
Calcium 300-600 mg
Phosphorous* 300-600 mg
Magnesium 80-140 mg
Iron 10-14 mg
Zinc 11-14 mg
Copper 1.4-1.8 mg
Selenium 20-40 mcg
Iodine 70-140 mcg
Vitamin A (Retinol Equivalent) 0.8-1.2mg RE
Vitamin B1(Thiamine) 0.5 mg minimum
Vitamin B2(Riboflavin) 1.6 mg minimum
Vitamin B3(Niacin) 5 mg. minimum
Vitamin B5(Pantothenic acid) 3 mg minimum
Vitamin B6(Pyridoxine) 0.6 mg minimum
Vitamin B7(Biotin) 60 mcg minimum
Vitmain B9(Folic acid) 200 mcg minimum
Vitamin B12(Cyanocobalamin) 1.6 mcg minimum
Vitamin C(Ascorbic acid) 50 mg minimum
Vitamin D(Cholecalciferol) 15-20 mcg
Vitamin E(Tocopherol) 20 mg minimum
Vitamin K(Phytonadione) 15-30 mcg
Vitamin A (Retinol Equivalent) 0.8-1.2mg RE
10
Vitamin B1(Thiamine) 0.5 mg minimum
* Expressed in terms of non-phytate Phosphorus
2 F75 Therapeutic diet
Nutritional composition per 100 g
Moisture content 5% maximum
Solubility index 0.5 ml maximum
Burnt particles 15 max
Energy approximately: 428 kcal.
Protein 5% of total energy
Carbohydrate 64% of total energy
Lactose 7.3 g
Lipids 32% of total energy
n-6 fatty acid 3 -10% of total energy
n-3 fatty acid 0.3- 2.5% of total energy
Sodium 87mg maximum
Potassium 737 - 938 mg
Calcium 300 – 600 mg
Phosphorus 300 – 600 mg
Magnesium 48 - 64 mg
Iron 0 – 0.3 mg
Zinc 11 - 18 mg
Copper 1.4 – 1.8 mg
Selenium 20 - 40 µg
Iodine 70 - 140 µg
Vitamin A 0.8 – 1.6 mg
Vitamin D3 15 – 20 µg
Vitamin E 20 - 25 mg
Vitamin K 15 - 30 µg
Thiamine 0.5 mg minimum
Riboflavine 1.6 mg minimum
Ascorbic acid 50 mg minimum
Vitamin B6 0.6 mg minimum
Vitamin B12 1.6 µg minimum
Folic acid 200 µg minimum
Niacin 5 mg minimum
Pantothenic acid 3 mg minimum
Biotin 60 µg minimum
10
3 RUTF, F75 and F-100 microbiological
*Pooling of samples to a maximum of 375g is acceptable, if the method is
validated
** Pooling of samples to a maximum of 300g is acceptable, if the method is
validated
RUTF
Risk Sampling Plan Specifications
Salmonella*
25 samples/25 g negative in 25g
(Testing method:
ISO 6579)
Enterobacteriaceae (EB at
37ºC)
10 samples/10 g maximum 10cfu in
1g (Testing
method: ISO
21528)
C. Sakazakii
In case
Enterobacteriaceae
is > 10cfu/gram (but
max. 2 samples are
between 10 and 100)
then additional
testing presence of
C. Sakazakii must be
carried out.
Maximum 10cfu in
1g (Testing
method: ISO
22964)
Total Aflatoxin 3 samples/250 g 5 PPB maximum
F75 / F100
Risk Sampling Plan Specifications
Salmonella*
60 samples/25 g negative in 25g
(Testing method:
ISO 6579)
C. Sakazakii**
30 samples/ 10 g negative in 10g
(Testing method:
ISO 22964)
1000
4 Super Cereal- Corn Soya Blend with Sugar
Main composition - Nutritional composition per 100 g
Moisture 10.0 % (maximum)
ISO 712-2009
Protein 14.0 % (N x 6.25) (minimum)
AOAC 981.10 ISO 20483:2006
Fat 6.0 % (minimum)
AOAC 954.02 ISO 11085:2008
20
Crude fibre 3.8 % (maximum)
AOAC 962.09
Ash 4.1 (maximum) ISO 2171:2007
Chemico-physical characteristics of flour
Peroxide value 10.0 meq/kg fat (maximum)
AOAC 965.33
Urease index 0.20 pH units (maximum)
AOCS Ba 9-58 (1997)
Particle size - 95% must pass through a 600 microns sieve - 100% must pass through a 1,000 microns sieve
