aseptics

Question 1

what does aseptic mean and why is it used ?

Answer 1

Free from contaminating organisms e.g. fungi or bacteria (sterile environment)
Aseptic technique is a procedure used by medical staff to prevent the spread of infection:
Sterile environment
Sterile equipment
Sterile manipulation techniques

Question 2

what does enteral mean?

Answer 2

Enteral

Of or relating to the intestines (e.g. administered by mouth, orally, via tube)

Question 3

what does parenteral mean ?

Answer 3

Parenteral

Introduced other than by way of the intestine (e.g. Intravenous, intramuscular, subcutaneous

Question 4

what products are made by aseptic techniques and why

Answer 4

Chemotherapy (cytotoxics)
Methotrexate
Herceptin (trastuzimab)
Many many more…………………..

Radiopharmaceutical (used for imaging)
Technetium 99

Total parenteral nutrition (TPN)
Adult
Neonatal

Risks to patients are greater when injectable medicines are prepared in clinical areas, such as wards and operating theatres, than when they are prepared in pharmacy under appropriate standards

Question 5

what patients is it targeted for?

Answer 5

Immunocompromised
Via a disease state
Via a drug regimen
Stage of development (neonatal)

Hospitalised patients
Inpatients on longer treatments

Versatility of dose and administration

Safety of staff

Safety for patients

Question 6

what are the key legislations

Answer 6

-the medicines act
-orange guide
-farewell report
Breckenridge Report 1976

Question 7

what does medicine acts 1968 cover ?

Answer 7

Medicines Act 1968 covers:

Administration, licences and certificates relating to medicinal products including clinical trials, retail pharmacy, general sales of medicines, prescription only medicines, labelling of medicinal products, British Pharmacopoeia and other publications

and section 10 and manufacturers license

Question 8

what is stated in the section 10 - prep

Answer 8

• Max. 7 day expiry
• Items prepared of directly supervised by a pharmacist
• Product preparation for specific patient in accordance with a prescription
• Products released by any appropriately trained pharmacist
• Local/regional audit

Question 9

what is stated in the manufacturers license

Answer 9

• Expiry based on stability data
• Items prepared by a suitably trained person following procedures (no direct supervision)
• Can prepare items for use as stock (i.e. batches)
• Pharmacist releasing items must be registered with MHRA (“Qualified Person” QP)
• MHRA inspection every 2-3 years

Question 10

what does this legislation cover?

Rules and guidance for Pharmaceutical manufacturers and distributors (orange guide)

Answer 10

Promotes Good Manufacturing Practice (GMP)

Recommends steps which should be taken by manufactures to ensure that their medicinal products are of the nature and quality required for administration to humans

Compliance with the principles and guidelines of GMP is a legal requirement within the European Economic Area

Question 11

What does GMP mean?

Answer 11

GMP is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:

Be of consistent high quality
Be appropriate for their intended use
Meet the requirements of the marketing authorisation (MA) or product specification

Question 12

what does this consists of?

Breckenridge report

Answer 12

IV drugs usage increased during 1970s and they predominantly made up on the wards
Reports of contamination and incompatibilities

As a result, the preparation of IV injections and infusions are the responsibility of the hospital pharmacy department

But not all are restricted to preparation in the Pharmacy department, e.g., IV antibiotics are made up by nurses

Question 13

Farwell report

Answer 13

In 1994 two children in Manchester died whilst receiving parenteral nutrition

Cause : Transfer of micro-organisms from a sink into transfer tubing that had been used for a week to prepare PN in the hospital pharmacy
Recommendation : Ensure standards of practice are in place in pharmacy aseptic units

Question 14

what is the definition of contamination

Answer 14

Contamination – “Any effect or action that has a negative impact on product’s integrity making it unfit for use”

-bacteria
-fungi
viruses
toxins
chemicals
dust

Question 15

what can contamination effect ?

Answer 15

Chemical composition 
pH 
Sterility (microorganism contamination)
Pyrogenicity 
Biological or therapeutic potency 
Physical appearance 
Particulate matter

Question 16

What is the purpose of a laminar flow cabinet

Answer 16

Provide a unidirectional stream of filtered air (protecting the product from contamination)

Question 17

what is the 2 types of laminar flow cabinet?

Answer 17

Horizontal – for dispensing of non-hazardous products (parenteral nutrition)
Vertical – Products which are hazardous to the operator (product contained within the cabinet thereby protecting the operator)

Question 18

what is horizontal laminar low cabinet used for?

Answer 18

for dispensing of non-hazardous products (parenteral nutrition)

Question 19

what is vertical laminar low cabinet used for?

Answer 19

Products which are hazardous to the operator (product contained within the cabinet thereby protecting the operator)

Question 20

how does the airflow work in the laminar flow cabinet?

Answer 20

Stage 1. Dirty room air enters the air cleaner
Stage 2. Air is processed through a Pre-filter where some particles are absorbed
Stage 3. Air is purified through a final HEPA filter with efficiency up to 99.97% on particulates down to 300 nm in size
Stage 4. Clean air is discharged into the work area creating a positive pressure laminar flow hood

Question 21

what is the function of isolators

Answer 21

Differ form laminar flow
Are completely enclosed
Increased safety from toxic or radioactive products

Question 22

what are the 2 types of isolators?

Answer 22

Positive pressure (pressure higher inside the isolator)
Negative pressure (pressure lower inside the isolator)

Question 23

what does HEPA filters do? ( high efficiency particulate air)

Answer 23

Removes aerosols, viable and non-viable particles from air
Provides air cleanliness to controlled workspace
Protect external environment
Only removes particles (liquid or solid) and not vapours or gases
MPPS (most particle penetrating size) < 0.1 µm diameter
These particles are trapped (they stick to the fibres) through a combination of four mechanisms
Interception
Impaction
Diffusion
Sieving

Question 24

how many clean rooms are there?

Answer 24

There are 4 classes of clean zones

The grade is defined by the type of product and the part of the process which needs to be protected from contamination

Question 25

what are the 4 clean rooms called?

Answer 25

A – High risk operations
B – Background environments for zone A
C & D – Clean zones for less controlled stages of manufacturing

Question 26

what are the 3 types of environmental monitoring/testing

Answer 26

Physical Tests
Microbiological Tests
Chemical Tests

Question 27

what does physical testing consist of?

Answer 27

Gauge checking for pressure and filter 
Status of rooms 
Pressure and filter status of laminar air flow cabinets (LAFC) 
Glove leak test in isolators 
Isolator leak test 
Integrity of the filters 
Particle count 
Room air change rates
LAFC/isolator velocity

Question 28

what does microbiology tests consists off

Answer 28

Settle plates
Contact plates 
Swabs 
Finger Dabs (touch plates)
Active air samples

Question 29

what does chemical tests consists off

Answer 29

Surface swabs for chemical residues

Surface wipes for chemical residues

Question 30

microbiology test :

what is a settle plate test?

Answer 30

-These are agar plates that placed within the clean room or with an isolator/laminar flow where the operators are working, and is trying to detect microbes that are in circulating in the air in main working room. Any microbes that land on the plate will grow when incubated