Unit 1 Sterile Preparation And Aseptic Technique Flashcards
What is Steril Preparation?
A dosage form of a drug free from microbes and chemical-physical contamination, posing no risk to the patient.
USP Standards.
What does the preparation of sterile pharmaceutical products in hospitals include?
The aseptic preparation of products and the preparation of terminally sterilized products.
Why are sterile preparations considered high-risk category products?
Due to uncontrolled environments that increase the risk of systemic infections and microbiological contamination
What are the principles of quality assurance system in sterile preparations ?
- Protect public health
- To ensure that the quality of these preparations consistently complies with defined requirements
- Protect public healthensure high quality, safe and effective to end users
What does Quality Assurance encompass?
A set of policies and procedures for ensuring quality in the manufacturing process and continuously improving product consistency.
Quality assurance ensures
- sterile preparations are planned and prepared according to the latest state of knowledge
- production and control operations are clearly specified according to Good Preparation Practice
- sterile preparations correctly processed, checked and stored according to procedure and released by a competent person
Principles of documentation
- approved, signed and dated by responsible person
- alteration is legible, clear and unambiguous
- traceability of the preparation process of a sterile preparation
- equivalent measures is applied to electronic record
- procedures, preparation instructions and record shall be retained for at least five years
Standard Operating Procedures SOP shall be written in imperative and include
- control of documentation system
- training personnel
- maintenance of equipment
- cleaning and disinfection
- procedures for monitoring
Records that shall be maintained for a period of time for legislations and local document control policies
- batch preparation record
- quality control test
- monitoring
- maintenance
- education and training
- validation
-statistics
-distribution
Personal responsibilities
Pharmacist in charge
- environmental monitoring of clean room and equipment
- send out settle plate and contact plate for testing
- approve of environmental monitoring result
Hospital support services and testing agent
- ensure testing agent has accreditation
- execution of test and data collection
- submit test report to person in charge
Sterile Preparation facilities
CDR preparation facility
-available in every state and hospital
Parenteral Nutrition Preparation Facility
-available in hospital with ICU, NICU and surgical department
Clean room
-proposed layout plan, grades and control parameter shall be submitted to the Pharmacy Practice and Development Division of the Ministry of Health for approval
Types of preparation of sterile pharmaceutical product
Eye Drop, Cytotoxic drug, non cytotoxic drug
Facility requirement
CDR facility, non CDR facility, both, premises and utilities for CDR facility separated from non CDR facility like eye drop, IV, parenteral nutrition
Define clean room
A room that has HEPA filtration to remove particles from the air
- for manufacturing where high level of cleanliness and sterility are required
Hepa filter
Maintenance of contamination control
- filter particles as small as 0.3 microns with 99.97 % minimum particles
- types are vertical or horizontal
