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Certificate of Analysis, Quality and Conformity: Certified: ISO 9001:2008, ISO 13485-2003 and WHO GMP

This certificate summarizes test results for a lot of MacConkey agar. The agar was tested for appearance, gelling properties, pH, cultural response to various microorganisms, and more. All tests met specifications. The material is certified as approved and manufactured under ISO and WHO GMP standards. The certificate provides quality assurance for the lot to be used as intended in microbiological testing applications.

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Mitha Arianti
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135 views

Certificate of Analysis, Quality and Conformity: Certified: ISO 9001:2008, ISO 13485-2003 and WHO GMP

This certificate summarizes test results for a lot of MacConkey agar. The agar was tested for appearance, gelling properties, pH, cultural response to various microorganisms, and more. All tests met specifications. The material is certified as approved and manufactured under ISO and WHO GMP standards. The certificate provides quality assurance for the lot to be used as intended in microbiological testing applications.

Uploaded by

Mitha Arianti
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 3

Certified : ISO 9001:2008, ISO 13485-2003 and WHO GMP

-------------------------------------------------------------------------------------------------------------------------------------------------------------------
HiMedia Laboratories Private Limited
23, Vadhani Industrial Estate, L.B.S. Marg, Mumbai - 400086
Website : www.himedialabs.com, Email : [email protected]

Certificate of Analysis, Quality and Conformity

Material Code : MH081 Material Name : Lot No : 0000279619


MacConkey Agar

Report No.: 040000679495 Date of Report : 19.10.2016 Expiry Date : Oct-2021

Appearance
Light yellow to pink homogeneous free flowing powder . Observed : Beige

Gelling
Firm comparable with 1.35% Agar gel.

Colour and Clarity of prepared medium


Red with purplish tinge coloured clear to slightly opalescent gel forms in Petri plates.

pH
pH of 4.95% w/v aqueous solution at 25C (after sterilization). pH Range :6.90-7.30 Observed : 7.29

Cultural Response
Growth Promotion is carried out in accordance with the harmonized method of ICH (USP/EP/BP/JP). Cultural response was
observed after an incubation at 30-35C for 18-72 hours. Recovery rate is considered as 100% for bacteria growth on
Soybean Casein Digest Agar.

Growth promoting properties


Growth of microorganism comparable to that previously obtained with previously tested and approved lot of medium occurs
at the specified temperature for not more than the shortest period of time specified inoculating 100 cfu (at 30-35C for 18
hours).

Indicative properties
Colonies are comparable in appearance and indication reaction to those previously obtained with previously tested and
approved lot of medium occurs for the specified temperature for a period of time within the range specified inoculating <=100
cfu (at 30-35C for 18-72 hours).

Organism Inoculum Growth Observed Lot Recovery Colour of Incubation Incubation


(CFU) value (CFU) colony temperature period
Growth Promoting + Indicative
Escherichia coli ATCC 8739 83 luxuriant 79 95% pink-red with 35C 18Hours
bile precipitate
Additional Microbiological testing
Escherichia coli ATCC 25922 87 luxuriant 82 94% pink to red 35C 18Hours
with bile
precipitate
Escherichia coli NCTC 9002 83 luxuriant 80 96% pink to red 35C 18Hours
with bile
precipitate
Enterobacter aerogenes ATCC 87 luxuriant 80 91% pink to red 35C 18Hours
13048
Enterococcus faecalis ATCC 81 fair to good 29 35% colourless to 35C 18Hours
29212 pale pink

PAGE : 1/3
Certified : ISO 9001:2008, ISO 13485-2003 and WHO GMP
-------------------------------------------------------------------------------------------------------------------------------------------------------------------
HiMedia Laboratories Private Limited
23, Vadhani Industrial Estate, L.B.S. Marg, Mumbai - 400086
Website : www.himedialabs.com, Email : [email protected]

Certificate of Analysis, Quality and Conformity

Material Code : MH081 Material Name : Lot No : 0000279619


MacConkey Agar

Report No.: 040000679495 Date of Report : 19.10.2016 Expiry Date : Oct-2021

Salmonella Typhimurium 82 luxuriant 80 97% colourless 35C 18Hours


ATCC 14028
Staphylococcus aureus ATCC >=10 inhibited 0 0% - 35C 24Hours
6538
Staphylococcus aureus ATCC >=10 inhibited 0 0% - 35C 24Hours
25923
Salmonella Enteritidis ATCC 88 luxuriant 82 93% colourless 35C 18Hours
13076
Salmonella Paratyphi A 83 luxuriant 79 95% colourless 35C 18Hours
ATCC 9150
Salmonella Paratyphi B 79 luxuriant 76 96% colourless 35C 18Hours
ATCC 8759
Salmonella Typhi ATCC 6539 81 luxuriant 77 95% colourless 35C 18Hours
Salmonella Abony NCTC 6017 79 luxuriant 76 96% colourless 35C 18Hours
Proteus vulgaris ATCC 13315 85 luxuriant 80 94% colourless 35C 18Hours
Shigella flexneri ATCC 12022 84 fair to good 28 33% colourless 35C 18Hours
Staphylococcus epidermidis >=10 inhibited 0 0% - 35C 24Hours
ATCC 12228
Corynebacterium diphtheriae >=10 inhibited 0 0% - 35C 24Hours
type gravis
. ATCC is a registered trade mark of the American Type Culture Collection
. NCTC and National Collection of Type Culture are registered trade mark of the Health Protection Agency

Control Media :
. For Bacteria : Soyabean Casein Digest Agar / Columbia Blood Agar base enriched with 5% v/v Sheep/Horse blood.
. For Yeast & Mold : Sabouraud Dextrose Agar.

. All ISO 11133 : 2014( E ) control strains are included in the Quality parameter
. HiMedia Laboratories Pvt Ltd is certified for ISO 9001-2008, ISO 13485-2003 and WHO GMP.

Information for BSE/TSE Risk: The material was subjected to pH <= 7.0 and/or a temperature in excess of 75C for no less
than 2 hours during the manufacturing process. The bovine raw material for this product was collected entirely from Indian
Origin animals in a licensed based establishment. The animals are inspected under a Govt. approved veterinarian's
supervision and were apparently free from infectious and contagious diseases. BSE (Bovine Spongiform Encephalopathy)/
TSE (Transmissible Spongiform Encephalopathy) and dioxine are not known to exist in India. This material does not
contain, nor is derived from the specific risks material as defined in The Maharashtra Animal Preservation Act Govt. of
Maharashtra, India.

STATUS OF THE MATERIAL : APPROVED

This is to certify that this lot passes and it confirms to the above mentioned tests and specifications . The information given

PAGE : 2/3
Certified : ISO 9001:2008, ISO 13485-2003 and WHO GMP
-------------------------------------------------------------------------------------------------------------------------------------------------------------------
HiMedia Laboratories Private Limited
23, Vadhani Industrial Estate, L.B.S. Marg, Mumbai - 400086
Website : www.himedialabs.com, Email : [email protected]

Certificate of Analysis, Quality and Conformity

Material Code : MH081 Material Name : Lot No : 0000279619


MacConkey Agar

Report No.: 040000679495 Date of Report : 19.10.2016 Expiry Date : Oct-2021

here is believed to be correct and accurate, however, both the information and products are offered without warranty for any
particulars use, other than that specified in the current HiMedia manual or product sheets. The results reported were obtained
at the time of release.
This document has been produced electronically and is valid

Microbiologist/Analyst Dy QC/Dy QA Manager Quality Assurance Manager


19.10.2016

PAGE : 3/3

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