Sterility and Asepsis

Question 1

Why can Sterility test be inadequate ?

Answer 1

It only assures that part of the batch sampled is sterile

Question 2

Sterility testing relies on assurance that the batch was produced under homogenous conditions. TRUE or FALSE

Answer 2

TRUE

Question 3

When conducting a sterility test, the sample used should be representative of the whole batch. TRUE or FALSE

Answer 3

TRUE

Question 4

What does the GMP state about Sterility test ?

Answer 4

Sterility test is applied to the finished product as the last step in a series of controlled measures by which sterility is assured. The test should be validated for the products concerned

Question 5

Sterility tests should include samples from parts of the batch particularly at risk. TRUE or FALSE

Answer 5

TRUE

Question 6

In filled containers, at what point are samples particularly at risk ?

Answer 6

At the beginning and end of the batch

Question 7

During heat sterilisation, at what point are samples particularly at risk ?

Answer 7

During the coolest part of the process. Therefore samples should be taken from the coolest part of the load

Question 8

State the most common sterility test used ?

Answer 8

BP Sterility test (adopted by the European Pharmacopoeia)

Question 9

The BP Sterility test is incredibly complex and requires dedicated facilities such as ?

Answer 9

• Grade A laminar airflow cabinet in Grade B environment
• Expensive machinery

(- Often automated as of recent)

Question 10

Name the 2 methods used in BP Sterility testing. Which is preferred ?

Answer 10

1) Membrane Filtration (Preferred method)

2) Direct Innoculation

Question 11

During membrane filtration, the product is filtered through a 20mm disc. TRUE or FALSE

Answer 11

FALSE. It is filtered through a 50mm disc

Question 12

During membrane filtration, the culture media should be incubated for at least hoe many days ?

Specify at which temperatures for bacteria and fungi

Answer 12

7 days

30-35 degree celcius for Aerobic and Anaerobic bacteria

20-25 degree celcius for Fungi

Question 13

During Direct Innoculation, the product is filtered into the culture media. TRUE or FALSE

Answer 13

FALSE. The product id transferred directly into the culture media

Question 14

Direct Innoculation allows for the sample of dry products such as powders for injections and dressings. TRUE or FALSE

Answer 14

TRUE

Question 15

Direct Innoculation can be used for liquid products although what needs to occur in order for the process to work ?

Answer 15

The liquid must be at least 10x dilute

Question 16

Direct Innoculation involves the incubation of liquid products for how many days ?

Answer 16

14 days. (Growth found means batch is compromised)

Question 17

Sterility testing isn’t performed in hospital manufacture. TRUE or FALSE. Why ?

Answer 17

TRUE.

1) Products aren’t produced in batches
2) Sterility test can take up to 14 days (and most products have short expiry dates)

Question 18

We can assure sterility upon receiving sterile product from manufacturer by adhering to GMP through quality assurance processes such as ?

Answer 18

• Aseptic process
• Quality control of materials
• Validate all processes
• Air quality monitoring
• Routine environmental monitoring
• Cleaning process
• Training

Question 19

Define Asepsis

Answer 19

The (continuous state of) absence of harmful bacteria, viruses and other microorganisms (in other words sterility)

Question 20

Define Aseptic

Answer 20

Free from contamination caused by harmful bacteria, viruses or other microorganisms

Question 21

Medicines Act 1968 has been replaced with ?

Answer 21

Human Medicines Regulations 2012

Question 22

What does Part 3 of the Human medicines regulations 2012 state ?

Answer 22

Without a manufacturers licence, a person may not assemble or import (from a state other than an EEA state) any medicinal product

Question 23

What does Section 10 of the Part 3(Regulation 17) allow ?

Answer 23

Allows pharmacies to assemble products w/out a manufacturers licence

Question 24

Manufacture includes any process carried out in the course of making a product

Answer 24

LEARN

Question 25

Manufacture includes …

Answer 25

Any process carried out in the course of making a product (from scratch)

Question 26

Manufacture includes dissolving, diluting, mixing etc for administration. TRUE or FALSE

Answer 26

FALSE. This is known as assembling not manufacturing

Question 27

Define Assemble in relation to a medicinal product

Answer 27

Enclosing of a product into a container and labeling it before it is sold/supplied.

Question 28

What processes does the assembly of medicinal products include ?

Answer 28

Dividing, Packaging and Presentation of a product

Question 29

Aseptic dispensing is assembling under the Human Medicines Regulations 2012. TRUE or FALSE

Answer 29

TRUE

e.g: we wouldn’t just give a patient injection powder, dilute appropriately, draw up the correct dose etc

Question 30

State activities (exempt from licensing) that may be done by or under supervision of, a pharmacist in a hospital

Answer 30

• Preparation and dispensing of medicine in accordance with a prescription (given by a practitioner)
• Assembling of medication
• Preparation of stock of medicines (a limited batch) with a view to dispensing them (in accordance with a prescription given by a practitioner)

Question 31

State 6 differences b/wn products of Part 10 exemptions and products that have a manufacturers license

Answer 31

1) Part 10 exemption products have a maximum 7-day expiry
- Products with ML, expiry is according to stability evidence

2) P10E - Products have to be prepared or directly supervised by a Pharmacist
ML - Prepared by suitable trained person following approved procedures

3) P10E - Products must only be prepared against a legal prescription
ML; Can be prepared in batched for stock

4) P10E - Final check and release may be done together
ML; Final check and release must be done by separate people

5) P10E - Release may be done by any locally approved pharmacist
ML; Release may only be done by person registered by MHRA so Pharmacist or qualified person (QP)

6) P10E - Standards must comply with local and QA regional audit
ML; Standards must comply with MHRA inspection which is much more strignent