PHARMACEUTICAL

MICROBIOLOGY

FA2113
TEAM MS TEAM DSR
(PHARMACOCHEMISTRY) (PHARMACEUTICS –
• MARLIA SINGGIH BIOTECHNOLOGY)
• ELIN JULIANTI • DEBBIE S. RETNONINGRUM
• MUH. AZHARI • CATUR RIANI
• ANINDYAJATI
 Debbie S. Retnoningrum (DSR)
Marlia Singgih (MS)
dretnoningrum@gmail.com
marlia@fa.itb.ac.id
083821447515
0816611886
Catur Riani (CR)

Contact catur.riani.biotech@gmail.com
081364270120
Elin Julianti (EJ)
elin_julianti@fa.itb.ac.id Contact
081323588976
Anindyajati (AJ)
Muhammad Azhari (MA) anindyajati.anin@gmail.com
mazhari@fa.itb.ac.id 08562931866
087823865712 / 089652089404 (WA)
 CLASS RULES
Please attend the class ON TIME. Any TARDINESS will not be tolerated 
you’re not allowed to join the class when the class is already started.

Any use of phone is prohibited during the class. Set your phone in silent mode,
or turn it off would be better.

Honesty  any kind of copy paste / cheating will not be tolerated (academic
sanctions!)
Post-test  online (e-learning portal)

Participation in class  would be rewarded as 5% of total marks

ITB rules of class attendance  min. 80%

 CLASS RULES
Class would be divided into 2 schedule:
2-hours class (theory)
1-hour class (tutorial for practicum)  will be started next week

ATTENTION!

Attending the tutorial for practicum is MANDATORY for all students, no

EXCEPTION!
Skip this tutorial  you’re not allowed to join the practicum

Unable to attend the class due to illness must submit legal permission from
doctor

Any kind of fraud (e.g. illegal doctor permission) would be traced and punished.
 GRADING Based on Class Distribution

TEAM MS (35%) TEAM DSR (35%)

Practicum:

Tuesday – Thursday 13.00-17.00

Microbiology Laboratory (4th floor)
PRACTICUM
(30%) Pre-Test/Post Test
Discussion
Lab. Report (Hand-Written)
 PARTICIPATION REWARD
When you ask question or answer the question correctly from the
lecturer, you will be given a post-it and write down as below:

• NAME However, the post-it must be returned

• NIM right after class. We will not accept
• DATE any kind of the post-it submission
after the class.
• Q&A
 REFERENCES
• Denyer S.P., Hodges N.A., Gorman S.P., Hugo and Russell’s Pharmaceutical
Microbiology, 8th ed., 2011, Willey-Blackwell, New Jersey, USA.
• Denyer SP, Baird RM, Guide to Microbiological Control in Pharmaceuticals and
Medical Devices, CRC Press, New York, 2007
• Patrick Murray, Ken Rosenthal, Michael Pfaller, 2015, Medical Microbiology 8th
edition, Elsevier
• Michael T. Madigan, John M. Martinko, Kelly S. Bender, Daniel H. Buckley, David
A. Stahl, Thomas Brock, 2015, Brock Biology of Microorganism 14th edition,
Pearson
• Farmakope Indonesia Edisi V
• US Pharmacopoeia (USP)
• Martin JF, Garcia-Estrada C, Zeilinger S (Eds), 2014, Biosynthesis and
Molecular Genetic of Fungal Secondary Metabolites, Springer, New York
 COURSE OBJECTIVES
1. Knowledge : Describe and explain basic microbiology
knowledge, methods and its application in pharmacy.

2. Skills : Apply and demonstrate aseptic work,

sterilization process, identification bacteria with
conventional methods, calculate bacteria number in
samples, determine and measure antibiotic potency,
demonstrate PCR, electrophoresis of DNA & protein.

3.Competence :
1. Analyze and interpret data of basic microbiology
methods.
2. Competence : Summarize scientific article content in
written report and presentation.
 TOPICS UNTIL MID-TEST
Week#1 Introduction and laboratory safety (MS/EJ/MA)
Week#2 Structure and Function of Eubacteria, Archaebacterial, and Virus
(DSR/CR/AJ)
Week#3 Microbe Growth and Growth Control (DSR/CR/AJ)
Week#4 Variety of Microbe (DSR/CR/AJ)
Week#5 Identification of Prokaryotic Microbe and Virus (DSR/CR/AJ)
Week#6 Identification, characterization, and screening of Eukaryotic Microbe
(MS/EJ/MA)
Week#7 Role of Microbiology in Pharmacy (Guest Lecture) (DSR/CR/AJ)
Week#8 Mid-Test
 TOPICS UNTIL FINAL-TEST
Week#9 Protocol in Fungi Preservation (MS/EJ/MA)
Week#10 Microbiology Quality Standard for Pharmaceutical Products
(MS/EJ/MA)
Week#11 Compendial of Microbiology Assay (MS/EJ/MA)
Week#12 Presentation with Topic: Compendial of Microbiology Assay
(MS/EJ/MA)
Week#13 Eukaryotic Secondary Metabolite for Pharmaceutical Products
(MS/EJ/MA)
Week#14 Presentation (1) regarding structure and function of certain bacteria
and virus as well as their role in pharmacy (DSR/CR/AJ)
Week#15 Presentation (1) regarding structure and function of certain bacteria
and virus as well as their role in pharmacy (DSR/CR/AJ)
Week#16 Final-Test
Any Questions?
Laboratory Safety
Laboratory
Safety???
• Skills
• Knowledge
• Responsibility
 Topics in Laboratory Safety
1. Risk Evaluation: pharmaceutical
consideration, microbiological
consideration, risk quantification, risk
management
2. Microbiological Audit: Laboratory safety in
microbiology, training, auditor
3. Classification of microorganisms based on
risk of infection, distribution and its virulent
according to WHO
4. Management of Biosafety
5. Prevention and management of accident in
Microbiology Laboratory
Anything Inappropriate in This Picture???
 Good Laboratory Practice (GLP)
GLP

•Prepare Quality system of management control

•Manage
Ensure:
•Audit • Uniformity
• Consistency
•Report • Reliability
• Reproducibility
• Quality of Analysis
 GLP (Good Laboratory Practice)

• Receiving Sample and Preparation of Sample

• Procedure of Analysis
• Data Management, Review, and Approval
 Preparation
• Preparation of raw material
• Preparation of glassware and apparatus for making media
• Weighing and Mixing
• Sterilization of Media
• Mixing and Dispensing
• Labeling and Storage
• Quality Control
• Supplier/Vendor
 Why Audit?
• Pharmaceutical Industry has to guarantee their products to
be safe, qualified, and beneficial
• Audit is part of Quality Management System
• As a Control Function against contamination and
improvement
 Classification of Deficiency
(Penyimpangan)

• Critical Deficiency
• Major Deficiency
• Other Deficiency
 Critical Deficiency

• Very likely to cause risk to patient, can cause side effect,

accident, or death
• Possibility: potency of product is not suitable, not pure,
unclear identity, or the product is not safe to be
consumed
• Products should be withdrawn from market
 Major Deficiency

• Product is “out-of-specification”
• The effect is not directly to patient, but directly to the
product quality. In long-term usage with influence the
quality and become unsafe
• Example: broken packaging, etc
 Other Deficiency

• Deficiency which including violation of GMP (Good

Manufacturing Process)
• Not directly influence the product quality
• Example: Lack of Control Card in the warehouse, etc.
 Audit in Microbiology Laboratory

• Microbiology laboratory’s role in Pharmaceutical

Industry is checking the safety of raw material,
intermediate, and end-product.
• Also in training and education for the employees,
training in Good Contamination Control Practice
(GCCP).
 Topics Related to Audit in
Microbiology Laboratory
• Security of access
• Design and lay-out of laboratory
• Good housekeeping
• Validation of analytical methods
• Validation of equipments
• Maintenance and calibration of equipments
• Medium for microbial cultures
 GCCP (Good Contamination
Control Practice)
• Development of formula
• Process of formulation
• Design of facilities
• Problem solving
• Risk assessment (interpretation of microbiological data
in relation to products and its risk to patient
 HACCP

• Hazard Analysis of Critical Control Points (HACCP) is a

method to guarantee product quality and safety
• This concept is firstly applied in NASA in preparation of
astronaut’s food, then was applied by FDA-USA to all
pharmaceutical industries and food industries.
• Identification on every critical control points (CCP) to
become main activity in HACCP
 HACCP

• Each point of any process is specific in general to have

a chance to be contaminated by microorganism.
• Risk of every microbial contamination should be defined
and identified.
• Process to be controlled including: preparation,
manufacture, distribution, storage, and usage
 Laboratory Safety Covers:
• Building: roof and walls
• Room: floor, door, window, furniture, cleaning
• Equipments and instruments: installing and cleaning
• Pipes, Sewage
• Raw materials, intermediates, end product
• Water
• Packaging materials
• Laboratory coats, hygiene of workers
• Documents
 Risk Assessment and Management
Risk assessment is a term used to describe
the overall process or method where you:
 Identify hazards and risk factors that
have the potential to cause harm (hazard
identification).
 Analyze and evaluate the risk
associated with that hazard (risk
analysis, and risk evaluation).
 Determine appropriate ways to
eliminate the hazard, or control the risk
when the hazard cannot be eliminated
(risk control).
 Risk Assessment and Management

Five steps to risk assessment can be followed to ensure that your

risk assessment is carried out correctly, these five steps are:
1. Identify the hazards
2. Decide who might be harmed and how
3. Evaluate the risks and decide on control measures
4. Record your findings and implement them
5. Review your assessment and update if necessary
 Risk Ranking
Five steps to risk assessment can be followed to ensure that your
risk assessment is carried out correctly, these five steps are:
Risk Matrix
 Risk Ranking

• Risk level = Probability of occurrence x severity of occurrence

• Degree of probability :
5 : Definite or will be happen
4 : Very likely to happen
3 : Likely to happen
2 : Very rarely
1 : Unlikely
• Degree of Severity
5 : Fatal
4 : Serious accident (need hospitalized)
3 : Accident with 3 days off
2 : Small accident
1 : No accident

• A combination of : Degree and probability and severity will

indicate the risk level in managing the microorganism
 Risk Level

• Risk level 20 – 25 : Catastrophic (prohibited to be done)

• Risk level 15 – 19 : Serious (need special assessment)
• Risk level 10 – 14 : Significant (need general assessment)
• Risk level 4 – 9 : Minor (general assessment)
• Risk level 1 – 3 : Trivial (no need any written assessment)
Classification of Infective Microorganisms by Risk Group
• Risk Group 1 (no or low individual and community risk)
A microorganism that is unlikely to cause human or animal disease.
• Risk Group 2 (moderate individual risk, low community risk)
A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to
laboratory workers, the community, livestock or the environment. Laboratory exposures may
cause serious infection, but effective treatment and preventive measures are available and the
risk of spread of infection is limited.
• Risk Group 3 (high individual risk, low community risk)
A pathogen that usually causes serious human or animal disease but does not ordinarily
spread from one infected individual to another. Effective treatment and preventive measures
are available.
• Risk Group 4 (high individual and community risk)
A pathogen that usually causes serious human or animal disease and that can be readily
transmitted from one individual to another, directly or indirectly. Effective treatment and
preventive measures are not usually available.
 Pathogenic Microorganisms
• All microorganisms, including bacteria, virus, fungi, parasites,
that categorized in group hazard 2, 3, and 4
• Examples : (microbes used in EP 1997 for microbial
preservatives)
• Pseudomonas aeruginosa (2)
• Staphylococcus aureus (2)
• Candida albicans (2)
• Aspergillus niger (1)
• Escherichia coli (1)
• Zygosaccharomyces rouxii (1)
 Laboratory facilities are designated as :
• Basic - Biosafety Level 1
• Basic - Biosafety Level 2
• Containment – Biosafety Level 3, and
• Maximum Containment - Biosafety Level 4
• Biosafety level designations are based on composite of the
design features,
• Constructions, containment facilities, equipment, practices and
operational procedures
• Required for working with agents from the various risk groups.
 Relation of risk groups to biosafety levels, practices and equipment
Risk Biosafety Laboratory type Laboratory Safety equipment
Group Level practices

1 Basic – Basic teaching, GMT Open bench work

Biosafety Level research
1
2 Basic – Primary health GMT plus Open bench plus BSC for
Biosafety Level services; protective potential aerosols
2 diagnostic clothing,biohazar
services; research d signs
3 Containment – Special diagnostic As level 2 plus BSC and/or other primary
Biosafety Level services; research special clothing, devices for all activities
3 controlled access directional airflow
4 Maximum Dangerous As level 3 plus Class III BSC, or positive
containment – pathogen units airlock entry, pressure suits in conjunction
Biosafety Level shower exit, with class II BSCs, dobleended
4 special waste autoclave (through the wall),
disposal filtered air
Classification of Laboratory Depends On:
 Code of Practice

The international biohazard warning

symbol and sign must be displayed
on the doors of the rooms where
microorganisms of Risk Group 2 or
higher risk groups are handled.
Biosafety Level 1
Biosafety Level 2

Procedures likely to generate aerosols

are performed within a biological safety
cabinet. Doors are kept closed and are
posted with appropriate hazard signs.
Potentially contaminated wastes are
separated from the general waste
stream.
 Biosafety Level 3

The laboratory is separated from general

traffic flow and accessed through an
anteroom (double door entry or basic
laboratory – Biosafety Level 2) or an
airlock. An autoclave is available within
the facility for decontamination of wastes
prior to disposal. A sink with hands-free
operation is available. Inward directional
airflow is established and all work with
infectious materials is conducted within a
biological safety cabinet.
Biosafety Level 3
Biosafety Level 4
 Microorganisms Handled in Different BSL

HIV, H1N1, SARS, Rabies

Hepatitis A, B, C, Lyme Disease,

Salmonella, Mumps, and Measles

Non-infectious bacteria
Thank You