NTA Level 5 • Semester 2 • PST05208

Aseptic Processing

Pharmaceutics Theory and Compounding • Source Session/Topic 2

Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability.

Session 2: Aseptic Processing

Total Session Time: 60 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Give introduction of aseptic processing.

• Explain concept of aseptic processing

• Identify basic rules for effective aseptic processing

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board, chalk and whiteboard markers

• LCD projector and computer

• Figure.2. 1: Aseptic techniques

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 Minutes Presentation Introduction, Learning Tasks

15 Minutes Presentation Introduction to Aseptic Processing.

Brainstorming

10 Minutes Concept of Aseptic Processing

Presentation

Buzzing

4 20 Minutes Presentation Basic Rules for Effective Aseptic Processing

6 05 Minutes Presentation Key Points

7 05 Minutes Presentation Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Introduction to Aseptic Processing (15 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What is aseptic processing?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

Aseptic processing

• Is the processing and packaging of a commercially sterile product into sterilized containers

followed by hermetic sealing with a sterilized closure in a manners that prevents viable

microbiological recontamination of the sterile product.

• It require careful control of the aseptic environment, of personnel practices and procedures,

sterilization of equipment and components, extensive environmental monitoring, and many other

controls.

• The number of controls required and the severe consequences of control failure make aseptic

processing one of the highest-risk pharmaceutical processes. Quality risk management is an essential

tool in ensuring product quality.

STEP 3: Concept of Aseptic Processing (10 minutes)

Activity: Brainstorming (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are the concepts of aseptic processing?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Suitable measures must be taken to ensure the microbiological quality of pharmaceutical

preparations during manufacturing but also during packaging, storage and distribution is

maintained

• The requirements necessary to achieve strict asepsis include:

o sterile starting materials

o Sterile equipment

o Controlled environment

o Sterile containers

o Suitable technique by trained personnel

Figure.2. 1: Aseptic techniques

processing operation by Ranjith Kumar kankala (2012)

STEP 4: Basic Rules for Effective Aseptic Processing (20 minutes)

• Use a „no touch‟ technique whenever possible.

o Handle small articles with sterile forceps and, when sterile apparatus must be touched, handle

as distant as possible from the part which will come into contact with a sterile liquid or solid,

this rule applies even though sterile gloves may be worn

• Reduce air disturbances to a minimum

o Standard procedures should be designed to minimize movement of personnel within the clean

room. Objects should be positioned within reach under the laminar air flow cabinet. Sharp

and sudden movements should be avoided.

• Consider the arrangement of objects under the laminar air flow (LAF)

o Clean air should not flow over dirty articles to contaminate sterile articles, the cabinet should

not be loaded with unnecessary equipment, and materials required should be carefully

selected and arranged before beginning the procedure.

• Refuse to be distracted

o No interruption should be allowed until a set procedure has been completed.

STEP 4: Key Points (5 minutes

• Aseptic process requires careful control of the aseptic environment, of personnel practices and

procedures, sterilization of equipment and components, extensive environmental monitoring and

many other controls.

• The number of controls required and the severe consequences of control failure make aseptic

processing one of the highest-risk pharmaceutical processes. Quality risk management is an

essential tool in ensuring product quality.

STEP 5: Evaluation (5 minutes)

• What is aseptic processing?

• What is the requirements necessary to achieve strict asepsis

References

Nelson, Philip (1993). Principles of Aseptic Processing and Packaging (3 ed.). USA: GMA Science

and Education Foundation. Retrieved 19 April 2018. Sudan

D., David, Jairus R. (2013). Handbook of aseptic processing and packaging. Graves, Ralph H.,

Szemplenski, Thomas. Boca Raton: Taylor & Francis.

Hargreaves, Paul. (2018)"Recommendation on the Validation of Aseptic Processes". Pharmaceutical

Inspection Co-Operation Scheme. PIC/S. Retrieved 8 May 2018.New York

Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011). Tanzania

Pharmaceutical Handbook (2nd ed.). Dar es salaam:

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