Sterility and Asepsis Flashcards Preview

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Flashcards in Sterility and Asepsis Deck (31):

Why can Sterility test be inadequate ?

It only assures that part of the batch sampled is sterile


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



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



What does the GMP state about Sterility test ?

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


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



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

At the beginning and end of the batch


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

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


State the most common sterility test used ?

BP Sterility test (adopted by the European Pharmacopoeia)


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

- Grade A laminar airflow cabinet in Grade B environment

- Expensive machinery

(- Often automated as of recent)


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

1) Membrane Filtration (Preferred method)

2) Direct Innoculation


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

FALSE. It is filtered through a 50mm disc


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

Specify at which temperatures for bacteria and fungi

7 days

30-35 degree celcius for Aerobic and Anaerobic bacteria

20-25 degree celcius for Fungi


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

FALSE. The product id transferred directly into the culture media


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



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

The liquid must be at least 10x dilute


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

14 days. (Growth found means batch is compromised)


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


1) Products aren't produced in batches

2) Sterility test can take up to 14 days (and most products have short expiry dates)


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

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


Define Asepsis

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


Define Aseptic

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


Medicines Act 1968 has been replaced with ?

Human Medicines Regulations 2012


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

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


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

Allows pharmacies to assemble products w/out a manufacturers licence


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



Manufacture includes ...

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


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

FALSE. This is known as assembling not manufacturing


Define Assemble in relation to a medicinal product

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


What processes does the assembly of medicinal products include ?

Dividing, Packaging and Presentation of a product


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


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


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

- 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)


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

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