LABORATORY GUIDELINE

LABORATORY IMPLEMENTATION AND REPORT

• All experiments will be conducted in group.
• Before each lab, students are required to come out with lab planning and tasks for each lab
group members.
• Group leader will lead other group members for planning and delegation of task must be
agreed among group members.
• Each group members will take turn to be the group leader.
• Lab planning and task of each members to be written in Microsoft OneNote (by group).
• Students are allowed to discuss the finding from the experiment, but you are required to
write the lab report using Microsoft OneNote personally.
• Each students will be evaluated on practical skills based on their task for each experiment.
• Students are assessed through lab reports and practical skills using the rubrics given.
• Students are required to submit a lab report seven days after completion of the lab.

PENALTY
• Plagiarism is considered if
- a lab report is written without proper citation, reference
- lab reports are similar among group members.
• Penalty also will be enforced for late submission of the lab report.
• 5% of will be deducted from total marks of the lab report for students who commit
plagiarism and/or late submission.

LAB PLANNING & RECORD

• Lab planning should contain:
- Flowchart of the experiment
- Tasks (based on flowchart) and person in charge
- Details of chemicals and amount, consumables, instruments required for the lab.
- Calculation (if any) for the required materials, chemicals or reagent.
- Blank form for data recording
• Lab planning must be written in you own word and not to copy from the lab
manual.
• Raw data must be recorded immediately after completion of the lab.

CSB 30603 QA & QC IN BIOPRODUCTS

CONTENT OF LAB REPORT
Title
The title of the lab report should be descriptive of the experiment and reflect what the
experiment analyzed.
Ex: "Determining the Free Chlorine Content of Pool Water"
Abstract
Abstracts are a summary of the experiment as a whole and should familiarize the reader with
the purpose of the research. Abstracts will always be written last, even though they are the first
paragraph of a lab report. Not all lab reports will require an abstract. However, they are often
included in upper-level lab reports and should be studied carefully. When writing an abstract,
try to answer these questions:
• Why was the research done or experiment conducted?
• What problem is being addressed?
• What results were found?
• What are the meaning of the results?
• How is the problem better understood now than before, if at all?
Introduction
The introduction of a lab report discusses the problem being studied and other theory that is
relevant to understanding the findings. The hypothesis of the experiment and the motivation for
the research are stated in this section. Write the introduction in your own words. Try not to
copy from a lab manual or other guidelines. Instead, show comprehension of the
experiment by briefly explaining the problem.
Methods and Materials
The methods and materials section provides an overview of any equipment, apparatus, or other
substances used in the experiment, as well as the steps taken during the experiment. If using
any specific amounts of materials, make sure the amount is listed.
Ex: pipette, graduated cylinder, 1.13mg of Na, 0.67mg Ag
List the steps taken as they actually happened during the experiment, not as they were
supposed to happen. If written correctly, another researcher should be able to duplicate the
experiment and get the same or very similar results.
Results
The results show the data that was collected or found during the experiment. Explain in words
the data that was collected. If using graphs, charts, or other figures, present them in the results
section of the lab report. Tables should be labeled numerically, as "Table 1", "Table 2", etc.
Other figures should be labeled numerically as "Figure 1", "Figure 2", etc. Calculations to
understand the data can also be presented in the results.

CSB 30603 QA & QC IN BIOPRODUCTS

Discussion
The discussion section is one of the most important parts of the lab report. It analyzes the results
of the experiment and is a discussion of the data. If any results are unexpected, explain why
they are unexpected and how they did or did not effect the data obtained. Analyze the strengths
and weaknesses of the design of the experiment and compare your results to other similar
experiments. If there are any experimental errors, analyze them. Explain your results and
discuss them using relevant terms and theories. When writing a discussion, try to answer
these questions:

• What do the results indicate?

• What is the significance of the results?
• Are there any gaps in knowledge?
• Are there any new questions that have been raised?
Conclusion
The conclusion is a summation of the experiment. It should clearly and concisely state what
was learned and its importance. If there is future work that needs to be done, it can be explained
in the conclusion.
References
If using any outside sources to support a claim or explain background information, those
sources must be cited in the references section of the lab report. In the event that no outside
sources are used, the references section may be left out.
Formatting
Lab report shall be written with a consistent font size and type. Reference and citation shall
follow APA style.

Source of the guideline:

https://guides.libraries.indiana.edu/c.php?g=992698&p=7182653

CSB 30603 QA & QC IN BIOPRODUCTS

 LABORATORY MANUAL

EXPERIMENT 1

IDENTITY TEST FOR ASCORBIC ACID TABLETS (A BASIC TEST)

INTRODUCTION

The basic tests represent one of the many elements of quality assurance in pharmaceutical
supply system. They have been devised with the following objectives:

a. to provide a simple and readily applicable method for verifying the identity of a drug
substance, using a limited range of easily available reagents, when the labeling and
physical attributes give rise to doubt

b. to provide a practicable means of confirming the identity of a drug, when a fully

equipped laboratory is not available.

OBJECTIVE
To demonstrate simple identity test for over the counter product.

EXPERIMENTAL PROCEDURE
Description. Each tablet usually contains 50 mg of ascorbic acid.
Preparation of the sample
1. Weigh 1 tablet and calculate the amount equivalent to 0.3 0 g of ascorbic acid.
2. Grind the tablets, weigh out the above-calculated equivalent amount as powdered
material and use directly as the test substance, dividing it into 6 equal parts.
3. Shake 4 parts of the test substance with 20 ml of water, filter and use the fíltrate as the
test solution.

4. Suspend 1 part of the test substance in 10 ml of ethanol (~750 g/1) TS. Place 3 strips of
filter-paper into the suspension and allow the solution to ascend for about 4 cm. Take
out the strips, cut away the lower dipped portion as well as the part that has not been
wetted by the solution and dry the remaining part of the strips in air at room temperature
(test papers).

CSB 30603 QA & QC IN BIOPRODUCTS

Identity tests
a. Heating behaviour.
Heat a small quantity of the test substance in a test-tube; it melts, acquires a brown colour
and has an odour resembling caramel. Ignite the melt; it swells and burns.

b. Colour and other reactions

1. To 2.0 ml of the test solution add l.0 g of sodium hydrogen carbonate R and 20 mg of
ferrous sulfate R; a violet colour is produced. Add 2.0 ml of hydrochloric acid (~70 g/l)
TS; the colour disappears.
Alternative test by filter-paper technique:
On a test paper place 1 small drop of sodium hydrogen carbonate (40 g/l) TS, followed
by 1 drop of ferrous sulfate (15 g/l) TS; a violet spot is produced. Then apply, at the
same place on the test paper, 1 drop of hydrochloric acid (~70 g/1) TS; the spot
disappears.
2. To 2.0 ml of the test solution add 0.5 ml of potassium permanganate (10 g/1) TS; the
initial violet colour is immediately discharged but a slight brown precipitate may appear.
Alternative test by filter-paper technique:
On a test paper place 1 drop of potassium permanganate (10 g/1) TS; the violet colour
is discharged but a brown spot appears.
3. To 2.0 ml of the test solution add 2 – 3 drops of silver nitrate (40 g/1) TS; a dark grey
precipitate is produced.
Alternative test by filter-paper technique:
On a test paper place 1 drop of silver nitrate (40 g/1) TS; a dark grey spot is produced.

CSB 30603 QA & QC IN BIOPRODUCTS

 EXPERIMENT 2

MICROBIAL QUALITY TESTING OF HERBAL PRODUCTS

INTRODUCTION

In the manufacture, packaging, storage and distribution of pharmaceutical preparations, suitable

means must be taken to ensure their microbiological quality. The pharmaceutical preparations
should comply with the criteria given below:
• Herbal medicinal products consisting solely of one or more herbal drugs (whole, reduced
or powdered).
a. Herbal medicinal products to which boiling water is added before use.
Total viable aerobic count. Not more than 107 bacteria and not more than 105 fungi per
gram or per millilitre.
Not more than 102 Escherichia coli per gram or per millilitre, using suitable dilutions).
b. Herbal medicinal products to which boiling water is not added before use.
Total viable aerobic count. Not more than 105 bacteria and not more than 104 fungi per
gram or per millilitre.
Not more than 103 enterobacteria and certain other gram-negative bacteria per gram or
per millilitre .
Absence of Escherichia coli (1 g or 1 ml).
Absence of Salmonella (10 g or 10 ml).

OBJECTIVES
To demonstrate basic microbiological quality test for herbal-based product

EXPERIMENTAL PROCEDURE
a. Preparation of sample
Dissolve or dilute 1 g of the product to be examined in sterile distilled water pH 7.0. In general
a one in ten dilution is prepared. However, the characteristics of the product or the required
sensitivity may necessitate the use of other ratios. If necessary adjust the pH to about pH 7 and
prepare further serial tenfold dilution using the same diluent.

CSB 30603 QA & QC IN BIOPRODUCTS

b. Total viable aerobic count
Surface-spread method
Using Petri dishes 9 cm in diameter, add 15 ml to 20 ml of a liquefied agar medium suitable for
the cultivation of bacteria (Nutrient Agar) or a liquefied agar medium suitable for the cultivation
of fungi (Potato Dextrosa Agar) at about 45 °C to each Petri dish and allow to solidify. Dry the
plates, for example in a LAF bench or in an incubator. Spread a measured volume of not less
than 0.1 ml of the sample prepared as described in the section Preparation of the sample over
the surface of the medium. Use at least two Petri dishes for each medium and each level of
dilution. For incubation and calculation of the number of colony-forming units proceed as
described for the pour-plate method. Compare the result of observation with acceptance criteria
as mention Introduction.

CSB 30603 QA & QC IN BIOPRODUCTS

 EXPERIMENT 3

DOWNSTREAM QUALITY CONTROL TEST

INTRODUCTION
Downstream processing which referred to the unit operations which are used to recover
bioproducts include those which facilitate disintegration of solids, separation and recovery of
solids and liquids, recovery of soluble molecules and the so-called finishing operations which
include processes such as drying and crystallization.

Thus quality control testing is conducted to ensure the safety, purity, identity, potency and
strength of the medicinal product, requiring multiple analytical methods that are rigorously
validated and monitored for robust performance.

CSB 30603 QA & QC IN BIOPRODUCTS

OBJECTIVE
To show examples of downstream quality testing

EXPERIMENTAL PROCEDURES
A. Water content / Loss on Drying
To measure the amount of water or volatile matter in a sample
1. Weight 5g of powdered drugs.
2. Dry the sample in the oven at 50 ˚C for 24 hrs.
3. Record the weight after 24hrs.
4. Calculate the following:
a. Moisture content
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊ℎ𝑡𝑡 𝑜𝑜𝑜𝑜 𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤
%= × 100
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊ℎ𝑡𝑡 𝑜𝑜𝑜𝑜 𝑑𝑑𝑑𝑑𝑑𝑑 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝
b. Loss of Drying
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊ℎ𝑡𝑡 𝑜𝑜𝑜𝑜 𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤
%= × 100
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊ℎ𝑡𝑡 𝑜𝑜𝑜𝑜 𝑤𝑤𝑤𝑤𝑤𝑤 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝
5. Compare the reading obtained with reading taken from moisture balance.

B. Bulk Density
Indicates the ability of the powder to “pack”
Measure the degree of packing or conversely the amount of space (void) between the particles
in powder

1. Place 20g of powdered drug sample into a graduated cylinder.

2. Read the volume taken by the sample.
3. Tap the sample few times until the reading is constant.
4. Record the number of tapped done.
5. Record the volume of the sample in cylinder.
6. Calculate the following:
a. Bulk or Apparent density
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊ℎ𝑡𝑡 𝑜𝑜𝑜𝑜 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠
𝑔𝑔�𝑚𝑚𝑚𝑚 =
𝑉𝑉𝑉𝑉𝑉𝑉𝑢𝑢𝑚𝑚𝑚𝑚 𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜 𝑏𝑏𝑏𝑏 𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤ℎ𝑡𝑡 𝑜𝑜𝑜𝑜 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 (𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢)
b. Tapped or True density
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊ℎ𝑡𝑡 𝑜𝑜𝑜𝑜 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠
𝑔𝑔⁄𝑚𝑚𝑚𝑚 =
𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉 𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜 𝑏𝑏𝑏𝑏 𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠
CSB 30603 QA & QC IN BIOPRODUCTS
 c. Bulkiness
𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉 𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜 𝑏𝑏𝑏𝑏 𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤ℎ𝑡𝑡 𝑜𝑜𝑜𝑜 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 (𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢𝑢)
𝑚𝑚𝑚𝑚 ⁄𝑔𝑔 =
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊ℎ𝑡𝑡 𝑜𝑜𝑜𝑜 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠
d. Carr’s Index
𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑏𝑏𝑏𝑏𝑏𝑏𝑏𝑏 𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑 − 𝐵𝐵𝐵𝐵𝐵𝐵𝐵𝐵 𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑
𝐶𝐶𝐶𝐶 (%) = × 100
𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 𝑏𝑏𝑏𝑏𝑏𝑏𝑏𝑏 𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑
e. Hausner ratio – Ratio of tapped bulk density and bulk density

C. Angle of Repose
To estimate flow properties of a powder

1. Pour 20g of powdered drug through a funnel onto a flat surface.

2. Measure the height and diameter of the resulting cone.
3. Determine:
Angle of repose = tan 𝜃𝜃 = ℎ⁄𝑟𝑟
Where h equals to the height of the cone and r equals to the radius of the cone

CSB 30603 QA & QC IN BIOPRODUCTS

 EXPERIMENT 5

MICROBIOLOGICAL ENVIRONMENTAL MONITORING

INTRODUCTION

The qualification, or requalification, of an aseptic manufacturing facility depends in large part

on the demonstration of controlled microbial conditions. There are a few methods that are used
for routine environmental monitoring in the premises of drug pharmaceutical or food bio
products manufacturers. The major components of environmental monitoring are as following:

PASSIVE AIR SAMPLING - Settle plates

Passive air sampling (i.e., settle plates) is a frequently used measure of clean room (or controlled
zone) monitoring. Settle plates have several advantages in this regard, chief among them the
ability to remain in continuous exposure for up to four hours (four hours is cited in European
Union [EU] 2008 guidance.

CSB 30603 QA & QC IN BIOPRODUCTS

OBJECTIVE
To introduce to the students example of method for environmental monitoring

EXPERIMENTAL PROCEDURES

1. Label the base of plates (the part containing the media) with the location, date, time, and
name of sampler.
2. Transfer the plates into the area/room where you want to test the cleaningness of
working environment.
3. Place plates at table/stand height if possible or another appropriate position.
(Worksurfaces must be disinfected before and after use).
4. Raise the lids of plates to expose the surface of the medium, rest the lid on the very edge
of the plate so that the entire agar surface is completely exposed, take care not to put
fingers on plates (refer to the pic below).
5. Leave plates exposed for four hours at all locations.
6. After exposure: replace lids of plates, and carefully incubate the plates at 30-35°C for
48 hours, Count the developed colonies and record the average results.

ACCEPTANCE CRITERIA

CSB 30603 QA & QC IN BIOPRODUCTS

REFERENCES:

World Health Organization. (1991). Basic tests for pharmaceutical dosage forms. World
Health Organization. https://apps.who.int/iris/handle/10665/40787

M. Ratajczak, M.M. Kubicka, D. Kamińska, P. Sawicka, J. Długaszewska, Microbiological

quality of non-sterile pharmaceutical products, Saudi Pharmaceutical Journal,Volume 23,
Issue 3, 2015, Pages 303-307, https://doi.org/10.1016/j.jsps.2014.11.015.

Kim Gail Clarke, 11 - Downstream processing, Editor(s): Kim Gail Clarke, Bioprocess
Engineering, Woodhead Publishing, 2013, Pages 209-234,
https://doi.org/10.1533/9781782421689.209.
https://www.usp.org/sites/default/files/usp/document/harmonization/gen-
chapter/g05_pf_30_6_2004.pdf

https://www.americanpharmaceuticalreview.com/Featured-Articles/169384-Role-of-
Environmental-Monitoring-and-Microbiological-Testing-During-Manufacture-of-Sterile-
Drugs-and-Biologics/
Guide to Good Manufacturing Practice For Medicinal Products Annexes, PE 009-16
(Annexes), 1 February 2022

CSB 30603 QA & QC IN BIOPRODUCTS

 UNIVERSITI KUALA LUMPUR
RUBRIC FOR LAB REPORT

EXPERIMENT TITLE Identity Test of Ascorbic Acid GROUP NUMBER REMARKS

COURSE CODE CSB30603
COURSE NAME QA & QC in Bioproducts
STUDENT NAME SUBMISSION DATE
STUDENT ID

Unsatisfactory Marginal Acceptable Exceptional

Dimension Criteria Weightage Marks Final Marks
(0.1 - 1.0) (1.1- 2.0) (2.1 - 3.0) (3.1 - 4.0)

KNOWLEDGE Demonstration of full knowledge of

1 Express knowledge in subject matter. NO grasp of information presented. Insufficient information presented. Acceptable information and explanation. 0
COGNITIVE the subject with supporting explanation.

Report structure
- Experimental procedure/flowchart
- Results
STRUCTURE - Discussion and Conclusion Absence of
2 Poor organized structure. Acceptable Organized Structure. Organized Structure. 0
AFFECTIVE - Referencing and Citation, structure.
- Standardized Formatting (Font type and size, reference
and citation format, etc),

Creativity Effort
- Diagram,
CREATIVITY Acceptable and Logical visual aids Very clear & creative integration of
3 - Arrangement of tables, NO visual aids used. Minimum use of visual aids. 0
COGNITIVE used. visual aids .
- Figures and charts,
- Formula derivation, etc

analyzing the topic given.

ANALYSIS OF DATA/TOPIC Analysis was done in a very logical
4 - Translate the raw data into a meaningful knowledge and NO analysis done. Minimum discussion and analysis done. Detail analysis was presented clearly. 0
COGNITIVE manner.
information.

DISCUSSION & CONCLUSION NO discussion done. no valid answer Minimum discussion done. minimum Acceptable discussion done. Detail discussion and answers done
5 Discussing and judgement by answering the questions 0
COGNITIVE was provided. answer was provided. Acceptable answer was provided. with clear elaboration.

Total Marks:(/50) 0
Percentage (%) 0
 Course: Group no:

Subject: Group members: Exp:

Component Activity Criteria Sub Criteria Level 1 (0.1-0.9 marks) Level 2 (1-1.9 marks) Level 3 (2-2.9 marks) Level 4 (3-4.4 marks) Level 5 (4.5-5 marks) Weightage Score

Selects and applies

Selects and applies Selects and applies
Selects inappropriate skills Selects appropriate skills appropriate skills and/or
appropriate skills and/or appropriate strategies and/or
Procedural and/or strategies required by and/or strategies required by strategies required by the
strategies required by the skills specific to the task X3
Knowledge the task and makes critical the task but makes critical task, but makes a number of
task with non-critical errors without error, and applies
errors in applying them errors in applying them non-critical errors in doing
in doing so some in innovative ways
so

Always need assistance in Sometimes need assistance Independently plan and Independently plan and Lead the planning and
Plan and Design the planning and designing a in planning and designing a design a task but without design a task with well- designing of a task with well-
X2
Task task with well-define task with well-define well-defined objectives and defined objectives and defined objectives and
objectives objectives outcomes outcomes outcomes

Performing Completely have no ideas on Little ideas on the use of Uses tools, equipment and Independently use tools,
experiments, task Independently use tools,
PRACTICAL the use of tools, equipment tools, equipment and materials with some equipment and materials with
Laboratory Work and analysis Use of Equipment equipment and materials with X2
SKILLS (PS) and materials and need full materials but need full competence without fully a high degree of competence
according to the competence
assistance assistance assistance and always help/guide others
objectives

Sometimes requires Rarely requires some

Always requires reminders to Always follow safety Routinely follows safety
Safety Precaution reminders to follow safety reminders to follow safety X1
follow safety procedures procedures procedures and guides others
procedures procedures

Routinely keeps work area

Always requires reminders to Sometimes requires Rarely requires reminders to Not requires reminders to
Work Area clean without reminders and X1
clean work area reminders to clean work area clean work area clean work area
encourage others

Sometimes requires Always returns equipment

Return of Always requires reminders to Rarely requires reminders to Not requires reminders to
reminders to return with no reminders and X1
Equipment return equipment return equipment return equipment
equipment encourage others

Total (/50) 0

Overall Comments:
Assessor's name:

Signature:

Date: