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Sterile Production Practical Flashcards

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1
Q

What does sterile pharmaceutical products include?

A

Chemotherapy drugs
Antibody preparation
Total parental nutrition
I.v additives
Eye products
Some medicated dressings

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2
Q

What are examples of potential contaminants ?

A

Microorganisms (fungi and bacteria)
Particulate matter (skin, hair, fibres, condenstate)
Pyrogens (endotoxin produced from Gram negative bacteria)

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3
Q

Why does sterile products matter?

A

To avoid serious errors which leads to harm and death
To ensure patients safety

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4
Q

What are the legal acts for sterilization ?

A
  1. Medicines Act 1968 (Section 10 exemption)
  2. Good manufacturing Practise GMP (Orange guide)
  3. EL(97)52 regulation (Aseptic preparation)
  4. QA of Aseptic services ( yellow guide)
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5
Q

What section from the medicine act 1968 is for sterile production?

A

Section 10 exemption

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6
Q

What is the orange guide ?

A

For sterile production manufacturing under Good Manufacturing Practice GMP

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7
Q

What is used legally for Aseptic prepration?

A

EL(97)52 regulation

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8
Q

What is used for Aseptic preparation services ?

A

The yellow guide -QA of Aseptic preparation services

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9
Q

For someone to manufacture sterile products what do they need legally?

A
  1. Special manufacturers license
  2. Prepared by Suitably Qualified Person
  3. Extended expiry- stability
  4. Batch prepared for stock
  5. Check and release by different people
  6. Product released by any registered person e.g pharmacist
  7. MHRA Inspection
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10
Q

Legal aspects when dispensing a sterile product ?

A
  1. Medicines act 1968 section 10 exemption
  2. Prepared/ supervised by pharmacist
  3. Max 7 day expiry - stability
  4. Prepared against Rx
  5. Check and release together
    6.Dispensed by any suitably qualified pharmacist
  6. Standards comply with local and regional QA
  7. Regional audit under EL(97)52
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11
Q

What is PQS?

A

Pharmaceutical Quality System
A system for sterile production that includes
Quality management
Documentation
Personnel and training

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12
Q

How is quality management applied in a pharmaceutical quality system ?

A

By ensuring that the medicinal product are of the quality required for their intended use which includes
Design
Validation
*Documentation control
*Training and SOPs
*Error reporting
Deviation management CAPA
Quality review
Internal audit
Product recall
Complaints

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13
Q

What are examples of documentation for a pharmaceutical quality system ?

A

Documents are recorded under policy and procedures , such as
1. worksheets,
2. labels
3. computer systems

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14
Q

How is personnel and training applied in a pharmceutical quality system ?

A

By distributing roles and responsibilites
By applying hygiene ,training and assesments

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15
Q

What are the Pharmaceutical quality system roles ?

A

1.Cheif pharmacist
2.Accountable pharmacist
3.Authorised pharmacist
4.Suitably qulaified pharmacist

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16
Q

What is the responsiblity for Chief Pharmacist ? In an PQS

A

An overall responsibilty and accountability for the PQS and the safesupply of medicines

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17
Q

What is the responsibilty for an accountable pharmacist? In an PQS

A

The named pharmacist responsible for all aspects of the aseptic preparation unit

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18
Q

What is the responsibilty for an Authorised Pharmacist? In an PQS

A

It is specifically designated to routinely supervise the aseptic process and release of products for use; includes Rx verification at an indivisual product level and ensuring that a clinival check has been carried out by a suitably qualified pharmacist.

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19
Q

What is the responsibilty for suitably qualified pharmacist ? In PQS

A

Any reg pharmacist but not specifically authorised to supervise routine aseptic preparation activities.

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20
Q

What is the enviorment needed for sterile production?

A

Designed (facilities and equipment)
Clean zones ( EU GMP Grade A-D)
Critical zone EU GMP Grade A (EC 2015)
validation
Validation master plan

Equipments needed
Laminar airflow cabinets -open
Isolator devices - closed
Clothing and PPE

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21
Q

What is needed for sterile of raw materials?

A

Gloves
Gown/apron

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22
Q

What is needed to set up a sterile enviorment?

A

Design
Clean zones
Critical zones EU

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23
Q

What is needed to prepare sterile product?

A

Gloves
Gown/ apron

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24
Q

What is needed to adminster sterile product?

A

Gloves
Apron/gown
Eye protection

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25
What is needed for waste disposal of sterile products ?
Gloves Gown Eye protection Respiratory protection
26
What is needed for spillage of sterile products?
Gloves Gown/apron Eye protection Respiratory protection
27
What is the role of a Chief Pharmacist?
Overall responsibility and accountability for the PQS and the safe supply of medicines
28
Accountable Pharmacist
The named Pharmacist responsible for all aspects of the aseptic preparation unit
29
Authorised Pharmacists
Specifically designated to routinely supervise the aseptic process and release products for use which includes Rx verification at indivisual product and ensure clinical check has been carried out by a Suitably Qualified Pharmacist.
30
What is the role of a Suitably Qualified Pharmacist ?
Any registered pharmacist but not specifically authorised to supervise or oversee routine aseptic preparation activies
31
What does COSHH regulations (2002) include?
Includes chemical, biological, but not radioactive subtance. Carcinogenes are included in appendix 1.
32
What does safety data sheet include?
Raw materials and control measures
33
What does risk assesment (5 steps) include?
Identify hazard who is at risk and how adequacy of existing measures documented risk assesments review date
34
How to safe handle storage and supply?
Shelving, security , packaging , transport
35
Safe handling spillage and waste disposal Procedures ?
Protect yourself and others, contain the spill, clean up and safely dispose of waste , document accident.
36
Waste disposal
Regulations Product waste Patient waste
37
Definition of aseptic processing ?
Method employed in pharmaceutical and healthcare industries to prepare sterile products by maintaining a completely germ-free environment throughout manufacturing
38
How to check product before release ?
1. Verification - Clinical suitable Qualified Pharmacist + aseptic services 2. Inspection 3. Reconciliation 4.Final product checks 5.Product approval (Release)
39
Why is sterilization important ?
These practices aim to protect healthcare professionals, patients, and the environment from adverse effects linked to exposure. Proper handling includes the use of personal protective equipment (PPE), adherence to established protocols, and the implementation of engineering controls to prevent contamination.
40
Explain the importance of using personal protective equipment (PPE) when handling hazardous drugs?
PPE prevents exposure to hazardous drugs It acts as a barrier, safeguarding healthcare professionals from potential health risks associated with these substances.
41
Describe the key components of an effective hazardous drug handling protocol?
An effective protocol includes: Proper storage and labeling of hazardous drugs. Use of closed-system drug transfer devices (CSTDs) to prevent leaks or spills. Implementation of engineering controls in the workspace. Regular training for healthcare personnel on safe handling practices. Adequate ventilation in areas where hazardous drugs are handled.
42
Why is it important to conduct calculations when preparing hazardous drug doses?
to ensure accurate dosing, minimizing the risk of under or overdosing. Precision in drug preparation to avoid adverse effects on patients and maintain the integrity of healthcare practices.
43
Discuss the potential risks of occupational exposure to hazardous drugs and strategies to mitigate these risks?
Risks of exposure include skin contact, inhalation, and ingestion, leading to various health issues. Mitigation strategies include using PPE, employing CSTDs, implementing proper ventilation, and regular monitoring of healthcare personnel for potential adverse effects.
44
How can healthcare professionals contribute to a culture of safety when handling hazardous drugs?
Applying protocols and guidlines training and education Reporting any incidents or concerns Promoting open communication about safety practices among team members.
45
You need to prepare 500 mL of a sterile solution with a concentration of 2% w/v. If you have a stock solution of the active ingredient at 5 mg/mL, what volume of the stock solution should you use?
100 mL
46
How can needle safe be sterilized?
Any conventenial sterilization method such as Alcohol Disinfectant solution Ethylene Oxide Gas Steam Autoclave Radiation
47
How are prescriptions verified?
Under BOPA standards of Rx verification process
48
What are the BOPA standards for Rx verification?
1. Check prescription details 2. Check prescription against protocol and treatment plan 3. Check patients details 4. Check adminstration details 5. Check calculations e.g dosage 6.check lab and crtical tests results 7.sign and date rx as a record of verification
49
What is a risk
The chance of something happening that will have an adverse impact on a patient.
50
How to minimise risk ?
By having SOPs Training Multiple safeguards i.e second checking Raising concerns when needed
51
How to manage risk ?
By reviewing incidence Encouraging error reporting Duty of Candour Changes in practise following RCA
52
What can minimise risk of incorrect adminstration route?
Safety alerts that are on labels or packaging of medicine
53
What must be available in areas of chemotherapy or immunodutalory agent preparation or adminstration?
Cytotoxic spillage kits Staff must be trained on appropriate cytotoxic spillage protocol Protect self, colleagues and patients Any cytotoxic spilagemust be reported via Datix
54
What is Extravasation?
It is a severe complication in the adminstration of cytotoxic chemotherapy . It causes pain, inflammation , discomfort and if left undiagnosed or inappropriately treated it can lead to necrosis, secondary infection and functional loss of the tissue.
55
How to manage a case of Extravasation?
1. Stop injection , leave cannula in place 2. Classify the agent using tables and treat as directed 3. Collect extravasation kit 4.Apply hot/ cold pack immediately (check flow chart) 5. Aspirate as much fluid as possible through cannula with 10 ml syringe , try to draw back 3-5 ml of blood 6. Mark extravasation area with permenant marker pen 7. Comtact patient doctor , nurses refer patient to hand team 8. Remove cannula only after approriate initial treatment below
56
Define sterility ?
The absolute freedom from all viable forms of life (essentialy microorganisms such as bacteria,fungi and viruses) and sterilisation process is producing a condition of sterility.
57
How can products be suitable for human administration?
Must be 1. Sterile 2. Free from contamination
58
What are contaminants divided into
Three main categories 1. Living (microorganisms) 2. Inert particulate matter ( glass, rubber dust ) 3. Pyrogens ( lipopolysaccaride from outer membrane gram - bacteria)
59
What are the issue to microorganisms contaminants if enters human body?
They can cause disease and infection
60
What will happen if particulate matter entered human body during adminstration ?
Particulate matter can cause inflammation of blood vessels ( phlebitis) or physical occlusion or blockage of blood vessels which may lead to thrombosis or embolism .
61
What are the issues of pyrogens entering during human adminstration ?
Can cause rapid increase of tempreture ( fever) Can be present even after sterilisation They are derived from bacteria so must prevent microbial contamination Can produce gram positive (mycobacteria, fungi,viruses) and gram negative bacteria (endoxins) Gram negative bacteria produces by pyrogens which are endoxins are a major issue.
62
What is the most important pyrogen ?
Endotoxin (gram negative) specifically lipopolysaccaride (LPS) coming from outer membrane of gram negative bacteria.
63
What is the pyrogenic activity?
Associated with the Lipid A portion of the LPS and many pyrogens can withstand sterilisation process (presented even after sterilisation)
64
What is Endoxin?
It is a gram negative bacteria in the outer membrane called Lipid A of lipopolysaccharide that is a potent pyrogen and poses a serious health risk if entered the body by adminstartion of contaminated medicines.
65
Which types of dressing must be sterile?
Dressings that are put on open wounds or burns must be sterile
66
Why must dressings that are put on open wounds or burns must be sterile?
To avoid infection
67
What are Ophthalmic products?
Eye products such as eye drops, eye ointments
68
Why must Ophthalmic products must be sterile?
To prevent infection of eye and abrasive damage to the eye.

Cancer Sterilization (1 decks)

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