Microbial analysis of non-
sterile pharmaceutical
products being
manufactured in a
pharmaceutical industry
Internship training programme carried out at
SUN PHARMA, HALOL, VADODARA.
By: Shrey Divecha (92100220058)
Priyanka Zala (92100220056)
Tanzirabanu Serashiya (92100220046)
MSc Microbiology Sem 4
MARWADI UNIVERSITY,RAJKOT.
INDEX
• Overview of the Company.
• Overview of the LAB.
• Works carried out at the LAB.
• Our Work
• Introduction and review of the literature.
Overview of the Company.
• Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth
largest specialty generic pharmaceutical company in the
world with global revenues of over 5.1 billion USD. Supported
by more than 40 manufacturing facilities, we provide high-
quality, affordable medicines, trusted by healthcare
professionals and patients, to more than 100 countries across
the globe.
• The head of company 0r the managing director (MD) is MR.
DILIP SANGHAVI.
• The company is established in year 1983.
• The company has various plants all over the country which
manufacture various kinds of pharmaceutical products.
• Our internship is being carried out at the HALOL plant.
• HALOL plant is the largest plant of the company.
• The plant contains various blocks in which different works are
carried out such as storage warehouses, testing laboratories
(chemistry and microbiology), manufacturing units, etc.
• The Microbiology laboratory of SUN PHARMA,HALOL is
situated in the OSD formulations building currently.
• The plant has managed to build a separate
building for QC Microbiology department that is the new
microbiology lab which is considered as Asia's largest
microbiology lab in any pharmaceutical industry.
• The microbiology lab contains of several sections :
Media section
Method Validation section
Testing areas (Old, New MLT) (Sterility)
Identification section
Media storage sections
BET section
Environmental monitoring section
Incubator section
General store of the lab.
Works carried out at the lab.
• Sample receiving in the sample receiving room.
• Media preparations in the media section.
• Sterility testing in the sterility testing aseptic area.
• MLT , Bioburden and other analytical testing in the old and new MLT
testing aseptic areas.
• Analysis, checking and observation of petri-plates received from other
departments in the Environmental monitoring section.
• Study of the growth observed in the petri plates from any
department or section in the Indentification section (ID)
• Bacterial endotoxin test in the BET section.
• For each and every process documentation is done.
OUR WORK
• Amongst the categories of pharmaceutical products that are
being manufactured at the plant that are:
- Parental/Sterile products
- Non-sterile products.
• We are studying the testings that are being done on some
non-sterile products.
• The testings for the non-sterile products are MLT(Microbial
Limit Test) and Bioburden.
INTRODUCTION TO THE OUR
WORK.
• Non-sterile products that we are studying are:
Pantoprazole
Anastrozole
Olanzapine
COMMONLY MEDIA USED FOR
TESTING.
• Soybean Casein Digest Medium (SCDM)
• Soybean Casein Digest Agar (SCDA)
• DEN Broth (DENB)
• Macon key Broth and Agar (MB & MA)
• Xylose Lysine Deoxycholate Agar (XLDA)
• Cetrimide Agar (CA)
• Mannitol Salt Agar (MSA)
• Sabouraud Dextrose Agar (SDA)
• Eosin Methylene Blue Agar (EMB)
PRODUCT TESTING
• It is the series of processes that are used for identification,
determination, separation, purification, and structure
elucidation of the given compound used in the formulation of
pharmaceutical products.
• In a pharmaceutical industry drugs are manufactured as
active pharmaceutical ingredients (API) and /or formulations
like oral tablets, capsules, syrups injections ointments, etc. of
drugs as per the standards declared by the Government of
India under the Drugs and Cosmetics Act and Rules as well as
Pharmacopeia of India's latest edition.
• While in SUN PHARMA it is the US pharmacopeia's latest
edition that is majorly followed as it is considered as one of
the standards among the pharmacopeias of other countries.
TOTAL AEROBIC MICROBIAL
COUNT (TAMC)
• Add 1 ml of sterile buffered sodium chloride peptone solution
in sterile Petri dish then add approximately 15 to 20ml of
sterile Soybean Casein Digest Agar by rotating and tilting the
plate, and allow medium to solidify.
• The temperature of media during transfer should be
approximately 45°C. Incubate these sterile Petri dishes at
30°C to 35°C for 3 to 5days. Keep the plates in inverted
position.
• Observe the result.
TOTAL COMBINED YEASTS AND
MOULD COUNT (TYMC)
• Add 1 ml of sterile buffered sodium chloride peptone solution
in Petri dish then add approximately 15 to 20ml of sterile
Sabouraud Dextrose Agar.
• Mix the contents of Sterile Petri dishes by rotating and tilting
the plate, and allow medium to solidify.
• The temperature of media during transfer should be
approximately 45°C.
• Incubate these Sterile Petri dishes at 20°C to 25°C for 5 to 7
days. O Keep the plates in inverted position.
• After completion of incubation period, observe the result.
TEST FOR SPECIFIC
MICROORGANISMS (PATHOGENS)
• The following pathogens are used for testing :
Escherichia coli.
Pseudomonas aeruginosa.
Staphylococcus aureus.
Salmonella abony.
Candida albicans.
Bile tolerant gram negative cocci.
Enterobacter spp.
Shigella spp.
• Among the above mentioned pathogens, 4 major groups are
frequently used in testing.
• These pathogenic groups are :
Escherichia coli.
Pseudomonas aeruginosa.
Salmonella abony.
Staphylococcus aureus.
• According to the microorganism, it’s selective media is
chosen and the respective tests are performed.
OBSERVATION OF THE RESULT OF
PATHOGENS
• Escherichia coli. : Observation of pink colored mucous
colonies over Macon key agar plate.
• Pseudomonas aeruginosa : Observation of greenish
colored colonies on Citrimide agar plate (CA)
+ve
-ve
• Salmonella abony: Observation of red colored colonies with
or without black center which indicates the presence of
Salmonella spp. On Xylose lysine deoxycholate agar
(XLDA).
• Staphylococcus aureus: Observation of yellow or white
colonies with yellow zone on Mannitol salt agar plate (MSA).
Thank You
