Lec 1- Aseptics

Question 1

Pre-requisites

Answer 1

• Knowledge of the BP and compounding
• Microbiology
• Dispensing process both within community and hospital pharmacy
• Some aspects of basic PK, Vd, steady state

Answer 2

• Staff have special requirements placed on them
• Pharmacists responsibility
• Standard operating procedures (SOP)- provide Quality assurance
• Errors are caused by
  
  • Inadequate communication between pharmacy and medical staff
  • Pharmacy labelling errors

Question 3

How

Answer 3

• Restricting contamination
• Designated zones for work within GMP specification
  
  • Incresed chekcs
• Clean rooms
  
  • No contamination of the product

Question 4

What are clean rooms

Answer 4

• A clean room is a room in which the number and concentration of viable and non-viable airborne particulates is controlled
• The room is constructed and used in a manner that minimises the introduction, generalisation and retention of particles inside the room, and other relevant parameters e.g. temperature and humidity are controlled as necessary
• Clean rooms require special clothing to protect the product
• The facilities are specialised

Question 5

Acceptable levels

Answer 5

• GMP guide give a range for particles in a given area
• Different grades have different ranges
• A= were medicines are made up = highest grade
• NB- can place isolator in other grades of the room as it is a sealed unit
• HEPA filters and pressure gradients
  
  • HEPA- (high-efficiency-particulate-arrestor)- bigger and more efficient HEPA filters in higher grade
  • Pressure- pressure inside the clean room is higher so when the door is opened air flows out toward the lower grade rooms preventing particles from entering higher grade area (clean air is pushed out)
  • Grade C/D= 20 changes per hour
  • B= 30 changes per hour

Question 6

Process and grading

Answer 6

A) Aseptic preparation- this is inside a laminar flow hood or inside an isolator

B) Background- The environment around the laminar flow hood

C) Preparation of solutions to be filtered/Changing room- Must be filtered to steralise otherwise A

D) Handling of components after washing or aseptic manipulation- Pharmacist checks finished products

D) ISOLATORS- isolators may be in a D site

Question 7

Minimum clothing requirements

Answer 7

• D area can just be in a lab coat
• C- overshoe, cuffs, total control of particle shedding

Question 8

Clean room typical layout

Answer 8

Question 9

Decide which grade each room would be

Answer 9

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