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Cancer Sterilization > Sterile Production Practical > Flashcards

Sterile Production Practical Flashcards

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
Q

What is needed for waste disposal of sterile products ?

A

Gloves
Gown
Eye protection
Respiratory protection

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26
Q

What is needed for spillage of sterile products?

A

Gloves
Gown/apron
Eye protection
Respiratory protection

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27
Q

What is the role of a Chief Pharmacist?

A

Overall responsibility and accountability for the PQS and the safe supply of medicines

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28
Q

Accountable Pharmacist

A

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

29
Q

Authorised Pharmacists

A

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
Q

What is the role of a Suitably Qualified Pharmacist ?

A

Any registered pharmacist but not specifically authorised to supervise or oversee routine aseptic preparation activies

31
Q

What does COSHH regulations (2002) include?

A

Includes chemical, biological, but not radioactive subtance.
Carcinogenes are included in appendix 1.

32
Q

What does safety data sheet include?

A

Raw materials and control measures

33
Q

What does risk assesment (5 steps) include?

A

Identify hazard
who is at risk and how
adequacy of existing measures
documented risk assesments
review date

34
Q

How to safe handle storage and supply?

A

Shelving,
security ,
packaging ,
transport

35
Q

Safe handling spillage and waste disposal
Procedures ?

A

Protect yourself and others, contain the spill, clean up and safely dispose of waste , document accident.

36
Q

Waste disposal

A

Regulations
Product waste
Patient waste

37
Q

Definition of aseptic processing ?

A

Method employed in pharmaceutical and healthcare industries to prepare sterile products by maintaining a completely germ-free environment throughout manufacturing

38
Q

How to check product before release ?

A
  1. Verification - Clinical suitable Qualified Pharmacist + aseptic services
  2. Inspection
  3. Reconciliation
    4.Final product checks
    5.Product approval (Release)
39
Q

Why is sterilization important ?

A

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
Q

Explain the importance of using personal protective equipment (PPE) when handling hazardous drugs?

A

PPE prevents exposure to hazardous drugs
It acts as a barrier, safeguarding healthcare professionals from potential health risks associated with these substances.

41
Q

Describe the key components of an effective hazardous drug handling protocol?

A

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
Q

Why is it important to conduct calculations when preparing hazardous drug doses?

A

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
Q

Discuss the potential risks of occupational exposure to hazardous drugs and strategies to mitigate these risks?

A

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
Q

How can healthcare professionals contribute to a culture of safety when handling hazardous drugs?

A

Applying protocols and guidlines
training and education
Reporting any incidents or concerns
Promoting open communication about safety practices among team members.

45
Q

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?

A

100 mL

46
Q

How can needle safe be sterilized?

A

Any conventenial sterilization method such as
Alcohol
Disinfectant solution
Ethylene Oxide Gas
Steam Autoclave
Radiation

47
Q

How are prescriptions verified?

A

Under BOPA standards of Rx verification process

48
Q

What are the BOPA standards for Rx verification?

A
  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
Q

What is a risk

A

The chance of something happening that will have an adverse impact on a patient.

50
Q

How to minimise risk ?

A

By having
SOPs
Training
Multiple safeguards i.e second checking
Raising concerns when needed

51
Q

How to manage risk ?

A

By reviewing incidence
Encouraging error reporting
Duty of Candour
Changes in practise following RCA

52
Q

What can minimise risk of incorrect adminstration route?

A

Safety alerts that are on labels or packaging of medicine

53
Q

What must be available in areas of chemotherapy or immunodutalory agent preparation or adminstration?

A

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
Q

What is Extravasation?

A

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
Q

How to manage a case of Extravasation?

A
  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)
  4. Aspirate as much fluid as possible through cannula with 10 ml syringe , try to draw back 3-5 ml of blood
  5. Mark extravasation area with permenant marker pen
  6. Comtact patient doctor , nurses refer patient to hand team
  7. Remove cannula only after approriate initial treatment below
56
Q

Define sterility ?

A

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
Q

How can products be suitable for human administration?

A

Must be
1. Sterile
2. Free from contamination

58
Q

What are contaminants divided into

A

Three main categories
1. Living (microorganisms)
2. Inert particulate matter ( glass, rubber dust )
3. Pyrogens ( lipopolysaccaride from outer membrane gram - bacteria)

59
Q

What are the issue to microorganisms contaminants if enters human body?

A

They can cause disease and infection

60
Q

What will happen if particulate matter entered human body during adminstration ?

A

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
Q

What are the issues of pyrogens entering during human adminstration ?

A

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
Q

What is the most important pyrogen ?

A

Endotoxin (gram negative) specifically lipopolysaccaride (LPS) coming from outer membrane of gram negative bacteria.

63
Q

What is the pyrogenic activity?

A

Associated with the Lipid A portion of the LPS and many pyrogens can withstand sterilisation process (presented even after sterilisation)

64
Q

What is Endoxin?

A

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
Q

Which types of dressing must be sterile?

A

Dressings that are put on open wounds or burns must be sterile

66
Q

Why must dressings that are put on open wounds or burns must be sterile?

A

To avoid infection

67
Q

What are Ophthalmic products?

A

Eye products such as eye drops, eye ointments

68
Q

Why must Ophthalmic products must be sterile?

A

To prevent infection of eye and abrasive damage to the eye.

Cancer Sterilization (1 decks)

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