The document summarizes an internship at ACI Pharmaceuticals Ltd from July 7-17, 2018. It discusses objectives of understanding how a pharmaceutical company operates and applying good manufacturing practices (GMP). Activities included quality assurance, microbiology, production, and warehouse operations. Specific microbiology tests conducted were bacterial endotoxin, microbial limit, sterility, and antibiotic assays. Environmental monitoring also helped ensure a safe working environment. The internship provided hands-on experience in pharmaceutical microbiology and insight into building a career in the industry.

1. Presentation
on
Internship at ACI Pharmaceuticals Ltd.
(07 July 2018 to 17 July 2018)
MD. INJAM HOSSAIN
ID-ASH1305013M

2. Objectives
To see and understand how a pharmaceutical company runs
To know how GMP is applied in the plant
To know about Standard operational procedure.
To develop our self completely for microbiology related job in pharmaceutical
company
To know how quality is assured

3. One of the leading pharmaceuticals
in Bangladesh.
First company in Bangladesh to
obtain certification of ISO 9001 in
1995.
Manufacture a wide rang of dosage
forms including: tablet, capsule, dry
syrup, ointment, MDI, ophthalmic
preparations etc.

4. Activities at ACI
Activities
HR &
Administration
Quality Assurance
Microbiological
Activities
Production
Engineering
Warehouse

5. Tests Conducted in Microbiological
Laboratory of ACI
Bacterial Endotoxin
Test (LAL Test)
Microbial Limit Test
Microbiological Assay
of Antibiotics
Sterility Test of Sterile
Pharmaceutical
Products
Analysis of Water
Environmental
Monitoring

6. Bacterial Endotoxin Test(LAL Test):
Equal volumes of test
solution & LAL reagents
are mixed in a test tube.
Incubate at 37°C for
1 hour.
Tubes are observed for
clot formation after
inverting them.
Formation of a solid gel
clot gives a positive test
of endotoxin presence
in the sample.
Figure: Gel Clot Method.

7. Microbial Limit Test (MLT):
MLT provides both qualitative and quantitative estimation of viable
microorganisms
The test includes total viable aerobic count (TVAC), total combined yeast
and mold count (TYMC)
Media : 1. Sabouraud Dextrose Agar (SDA)
2. Tryptic Soy Agar (TSA)
For determination of TVAC : TSA media used & incubate at 30-35 0C for 3
days
For TYMC : SDA media used & incubate at 20-25° C for 5 days

8. Sterility Test :
A test that assesses whether a sterile pharmaceuticals product is free from microorganisms.
“Membrane Filtration” is the most widely used method.
0.22 μm cellulose nitrate filter used.
Media: TGM(Thioglycollate Medium) for anaerobic bacteria & TSB(Tryptic Soy Broth)
for aerobic organisms.
For TGM incubation temperature is 30-35°C and for TSB 20-25°C.
Incubate media for 14 days.

9. Microbial Assay of Antibiotics:
Microbial assay is done to determine the “potency of antibiotics”.
Antibiotic potency is estimated by comparing the inhibition of growth of sensitive micro-organisms produced
known concentrations of the antibiotic being examined against a reference standard substance.
Two general methods are employed :1. Agar Diffusion,
2. Turbidometric method
“Agar Diffusion method” is widely used.

10. Environmental Monitoring:
 Definition: To observe the presence of harmful factors such as toxins, bacteria, chemicals and
other pollutants in a specific location.
 To be monitored :
I. Non-viable airborne particulates.
II. Viable airborne particulates.
III. Viable surface bound particulates on clean room surfaces & personnel.
 Types of Environmental Monitoring:
1. Settle plate
2. Air Sampler
3. Surface monitoring
4. Contact plate

11. Special Remarks
Sustain higher
quality (ISO 9001)
They are very helpful to
each other as well as to the
trainees.
Maintain “GMP”
in the production
area

12. Achievements From This Internship:
Practically learn to perform microbiological tests
required in pharmaceuticals.
Introduced with the environment & activities of a
pharmaceuticals which will help to build career in
this field.