Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms.
The presentation describes types advantages, disadvantages of parenteral preparations, route of administration, general requirement, evaluation, labeling & packaging, containers & their types etc
Page | 30
TESTS CONDUCTED IN MICROBIOLOGY LABORATORY OF ACI
❖ Bacterial endotoxin test (BET/LAL test/ Pyrogen Test)
❖ Microbial limit test for non-sterile pharmaceutical products (syrup, suspension, cream,
ointment, gel, tablet and raw materials)
❖ Microbiological assay of antibiotics
❖ Sterility test of sterile pharmaceutical products
❖ Sampling of water (purified water, potable water and water for injection)
❖ Sampling of raw materials
❖ Total organic carbon analysis (water for injection, purified water)
❖ Chemical analysis of water
❖ Environmental monitoring, settle plate
❖ Personal hygiene monitoring
❖ Surface monitoring
❖ Liquid borne particle count for WFI
❖ Preservative efficacy test
Media Used:
NON SELECTIVE MEDIA SELECTIVE MEDIA
R2A Agar Xylose Lysine Deoxycholate
Sabouraud dextrose agar Brilliant green lactose bile broth
Tryptone Soy Agar Bismuth sulphite agar
Tryptone Soy Broth
Eosine methylene blue agar
Thioglychollate medium Cetrimide agar
MacConkey agar
Triple sugar iron agar
Mannitol salt agar
Enterobacteriaceae enrichment broth
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Figure 11: Selective & Non selective media used in ACI
BACTERIAL ENDOTOXIN TEST
PRINCIPLE
BET test is used to detect or quantify bacterial endotoxins that may be present in the sample
to which the test is applied. Endotoxin is a toxic substance found in the outer cell membrane
of Gram negative bacteria (Lipopolysaccharide, LPS) when they disintegrated. The gel clot
method is a qualitative or semi-quantitative method, which detects the endotoxin based on
clotting of the Limulus Amoebocyte Lysate (LAL) reagent in presence of endotoxin when
incubated. LAL reagent is prepared from lysate of the circulating amoebocytes of the
horseshoe crab Limulus polyphemus. When exposed to minute quantities of endotoxin, the
lysate increases in opacity, viscosity and forms gel depending on the concentration of
endotoxin. The concentration of endotoxin required to cause the lysate to clot under standard
conditions is the labeled sensitivity of LAL reagent.
Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms.
The presentation describes types advantages, disadvantages of parenteral preparations, route of administration, general requirement, evaluation, labeling & packaging, containers & their types etc
Page | 30
TESTS CONDUCTED IN MICROBIOLOGY LABORATORY OF ACI
❖ Bacterial endotoxin test (BET/LAL test/ Pyrogen Test)
❖ Microbial limit test for non-sterile pharmaceutical products (syrup, suspension, cream,
ointment, gel, tablet and raw materials)
❖ Microbiological assay of antibiotics
❖ Sterility test of sterile pharmaceutical products
❖ Sampling of water (purified water, potable water and water for injection)
❖ Sampling of raw materials
❖ Total organic carbon analysis (water for injection, purified water)
❖ Chemical analysis of water
❖ Environmental monitoring, settle plate
❖ Personal hygiene monitoring
❖ Surface monitoring
❖ Liquid borne particle count for WFI
❖ Preservative efficacy test
Media Used:
NON SELECTIVE MEDIA SELECTIVE MEDIA
R2A Agar Xylose Lysine Deoxycholate
Sabouraud dextrose agar Brilliant green lactose bile broth
Tryptone Soy Agar Bismuth sulphite agar
Tryptone Soy Broth
Eosine methylene blue agar
Thioglychollate medium Cetrimide agar
MacConkey agar
Triple sugar iron agar
Mannitol salt agar
Enterobacteriaceae enrichment broth
Page | 31
Figure 11: Selective & Non selective media used in ACI
BACTERIAL ENDOTOXIN TEST
PRINCIPLE
BET test is used to detect or quantify bacterial endotoxins that may be present in the sample
to which the test is applied. Endotoxin is a toxic substance found in the outer cell membrane
of Gram negative bacteria (Lipopolysaccharide, LPS) when they disintegrated. The gel clot
method is a qualitative or semi-quantitative method, which detects the endotoxin based on
clotting of the Limulus Amoebocyte Lysate (LAL) reagent in presence of endotoxin when
incubated. LAL reagent is prepared from lysate of the circulating amoebocytes of the
horseshoe crab Limulus polyphemus. When exposed to minute quantities of endotoxin, the
lysate increases in opacity, viscosity and forms gel depending on the concentration of
endotoxin. The concentration of endotoxin required to cause the lysate to clot under standard
conditions is the labeled sensitivity of LAL reagent.
It is very brief outline for testing of sterile pharmaceutical preparations i.e parenteral. However, you people can improve the document for further use by referring to USP & BP.
YOUR COMMENTS WILL BE APPRECIATED.
THANKS
Rapid sterility testing system is an automated solution for the rapid detection, response, and resolution of microbial contamination in filterable samples throughout the manufacturing process. Accurate, rapid sterility testing is not only critical for patient safety it also makes great sense for the compounders and other pharmaceutical manufacturers.
It is very brief outline for testing of sterile pharmaceutical preparations i.e parenteral. However, you people can improve the document for further use by referring to USP & BP.
YOUR COMMENTS WILL BE APPRECIATED.
THANKS
Rapid sterility testing system is an automated solution for the rapid detection, response, and resolution of microbial contamination in filterable samples throughout the manufacturing process. Accurate, rapid sterility testing is not only critical for patient safety it also makes great sense for the compounders and other pharmaceutical manufacturers.
Testing a Food or Beverage product is conducted for estimating the
presence of microbial contamination, change in the pH, sensory
evaluation, Shelf Life and the quality of the water used in the preparation.
I am Seeking an opportunity in gulf area & Egypt , multinational organization
where I can gain practical experience and develop my skills to achieve professional and personal targets.
I have got advanced experiences at QMS ( ISO9001-ISO17025- ISO22000 / HACCP ) and processes establishing, compliance verification and systems auditing
Quality and Food Safety Auditor, GLP, GMP, Hygiene.
. I am14 year Experienced in Quality, HSE, R&D & Manufacturing Operations , Exposure in Multiproduct category i.e Pure natural Mineral water , Juices Beverages,Dairy, Fruit & Vegetable canning, Tomato concentrate processing,
I am Seeking an opportunity in Gulf area & Egypt , multinational organization where I can utilize my experience and my skills to enrich and develop my professional and personal targets."
A Dynamic Professional with over 14 years’ experience in Quality Management, Food Safety & Lab & CHAMICAL & MicrobiologyFOOD, innovation Management, , Cost saving & Supplier Development, Packaging Development, Co- manufacture & Co-Pacer Health and Nutrition, Food Regulations, Crisis Management, Contours improvement and People Management, leadership management, Team work
Expert in Quality Management Systems, GMP, HACCP,ISO 22000, Crisis Management,Risk Assessment,, Innovation, Management, Consumer Complaint, Product & Process Validation & Supplier development & Compliance and Regulatory
Smooth functioning of Microbiology section. Ensure quality of analytical tests performed. Provides technical assistance to market on Microbiology issues
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Personal:
Name : Ibrahim M. AL-Shatarat
Date of Birth : 17/01/1987
Nationality : Jordanian
Marital Status : Married
Iqama No. : 2324059001
Status of Iqama : Transferable
Address : KSA - DAMMAM
Mobile No. : +966(567858615)
E-mail : ibrahim_shatarat@yahoo.com
Academic Qualifications:
B.Sc. Degree in Applied Microbiology from Al-Balq'a Applied University,
Zarqa’a University College, Jordan.
From 2005 to 2009 with Good degree.
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Experiences:
1- Working in Arab Pharmaceutical Manufacturing Company (APM) apart of
HIKMA Group –Salt –Jordan.
Working as QC-Analyst (Microbiologist) at QC department from: 11/08/2009 –
01/05/2012.
2- Working in Arab Company for Pharmaceutical Products (Arabio), Makkah,
Kingdom of Saudi Arabia.
Working as QC-Analyst (Microbiologist) at QC department from: 11/05/2012 –
until 11/05/2014.
3- Working in Baxter Company Limited (BCL), of Saudi Arabia.
Working as QC-Analyst (Microbiologist) at QC department from: 22/06/2014 –
until now.
Computer & Skills:
Windows, Microsoft Office, Internet.
Language:
1. Arabic Mother Tongue
1. English
My experiences in Microbiology field are involved the
following:
1. Culture media:
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- Preparing all types of culture media.
- Mixing base ingredients to prepare special culture media that may not be present in the
market.
- Growth Promotion for each lot of prepared culture media.
- Inhibitory and Indicative Test for selective media.
2. Microorganisms’ Identification:
-Identification of all pathogenic bacteria, Molds and Yeast by using selective
media, biochemical tests or identification Kits such as API Identification Kit.
- Identification of all bacteria using Vitek compact 2 system.
3. Microbial limit test:
- Testing all types of products using Microbial limit test methods such as:
pour plate method, Filtration method and most probable number method to detect
the microbial limit of the tested products.
- Microbial contamination test to complete Microbial limit test to detect any
contamination in the tested product by using selective media, enrichment
media...est.
- Validation of all counting methods (suitability of counting methods) by using
further dilutions or suitable neutralizers according to the group that product
belong to it, refer to USP ,EP or BP.
4. Testing all forms of drugs:
(Tablets, Capsules, Syrups, Suspensions, Ointments, Creams, Injectable ect …..
5. Testing all types of raw materials
(Powder & liquids).
6. Testing all types of packaging materials
Such as bottles, tubes, and caps.
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7. Culturing for all types of Microorganism:
- Culturing of all types of microorganisms (bacteria, mold and yeasts from
reference lifolized swabs such as: ATCC swabs (culture maintenance) from
passage one to passage five.
- Preparation of microorganism's stocks and microorganism's dilutions.
-Determination (counting) the number of each stock or dilution by using pour plate
method to use them(microorganism dilutions and stocks) into several
microbial test such as :growth promotion test, Sanitizer Efficacy Test,
Preservative Effectiveness Test and Validation of counting methods.
8. Biological Assay & Immunology Assay:
- Biological Assay for all products that need determination of the concentration of
Antibiotics or Vitamins using:
- Turbidmetric methods.
- Cup Plate methods (Zone of Inhibition).
- Validation of Biological Assay Methods and Recovery of methods.
- Immuno Assay for vaccines' ( Identity Test ) using ELIZA Technique .
9. Sterility test:
- Sterility test for all products that require sterility test.
10. LAL Test:
a- Test the products using Gel Clot Technique to detect the presence or
absence of endotoxin in the tested product
(Qualitative or Quantitative test)
b- Bacterial Endotoxin Test using Kinetic Chromogenic Method & Kinetic
Turbidimetric Method.
- Confirmatory test for all LAL reagents before using or for other reasons.
- Validation of LAL test methods (Inhibition Enhancement Test) to determine
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the suitable Sensitivities and Maximum Valid Dilution (MVD) to be used.
- LAL test for LAL reagent water (LRW) and other types of water
that enter the manufacturing process.
11. Preservative (Challenge) test
(Test the efficiency for the preservative in the drugs).
12. Water Testing as USP and EP requirements.
-TYMC & TAMC, coliforms and Pseudomonas using filtration
method such as: Milliflex plus pump or pour plate method.
-Bacterial Endotoxin Test for Pure Steam and WFI samples .
13. Environmental Controlling.
-Testing the surfaces (Machines, Walls, Floors…) and test the environmental air
by using settling Plates or Air Sampler & Air Particulate Matter.
-Qualification for Aseptic Area Operators.
14. Solution Subvisible Particulate Matter Test.
-Testing all liquid products that required Solution Subvisible Particulate
Matter Test.
15. Sanitizers Efficacy test:
- Testing the activity of sanitizer against microorganisms.
16. Others:
- Media Fill : Participate in the validation of the Filling Line under
Aseptic Conditions
- UV Challenge test.
- Calibration of Balances, PH meter and all devices related to Micro -lab.
-IO, PQ and PQ for all microbiological instruments ( Autoclave ,
Oven, Incubators ,water Baths ….etc.)
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