IMPLEMENTATION OF ASEPTIC DISPENSING BASED ON PKPO 5 SNARS

DR.MOHD BAIDI BAHARI

AIMST UNIVERSITY

ASEPTIC DISPENSING

• ASEPTIC is define as free of contaminants especially microorganism. In

pharmaceutical preparations it covers microorganism as well as particulate

matters.

• DISPENSING is a process of preparing and giving out of substances or

services according to the plan or as prescribed.

PELAYANAN KEFARMASIAN DAN PENGGUNAAN OBAT PHARMACEUTICAL SERVICES AND MEDICATION USE (PKPO 5)

• 5 Rs for the medication use (component of PKPO 5)

• Right patients

• Right drug

• Right dose

• Right route

• Right time

NATIONAL STANDARD OF HOSPITAL ACCREDITATION (STANDAR NASIONAL AKREDITASI RUMAH SAKIT) SNARS

•Components of standard (1st Edition 2018)

• Patient safety

• Patient focus services

• Managements

• National program

STANDARD IN ASEPTIC DISPENSING

• The standard shall cover

• Right patients – Doctor must correctly diagnosed the patients and

prescribe drug according to the need of the patient’s therapy

• Right drug - must be the correct drugs as prescribed, prepared in

right environment, using right technique and must be sterile.

• Right dose – calculation, measurements and preparation must be

verified by the second qualified personnel.

• Right route – the best route to deliver the medication SQ, IM, IV, IT

etc.

• Right time – must be given at the right tine, duration and frequency.

STANDARD IN ASEPTIC DISPENSING

•The standard for environments

• A room which the concentration of airborne particles is controlled, and which

is constructed and used in a manner to minimize the introduction, generation,

and retention of particles inside the room and in which other relevant

parameters, e.g. temperature, humidity, and pressure, are controlled as

necessary.

STANDARD FOR ENVIRONMENT

•Available International standard

• Federal standard 209 D – American Standard

• ISO 14644-1 – The International Organization for Standards published in

1999 replace 209D

• Eastern Europe - GOST R ISO 14644-1-2002 “Clean rooms and controlled

media conditions”

• Australian Standard AS/NZS 14644 2002

• British Standard 5295

PARTICLE 0.5 MICROMETRES COUNTS

ZOONING CLEAN AREA

CLEANROOM DESIGN

STANDARD APPAREL FOR ASEPTIC DISPENSING

Gowning depends on the facilities available in the clean

room suit.

PERSONNEL APPAREL

ASEPTIC TECHNIQUE

• Staff involved in the preparation of drugs must:

• Fulfill health requirements for recruitment as reviewed by

physician

• Undergone basic aseptic training

• Assessed by Responsible Person

• Performed and passed processing validation

• Credentialing by Responsible Person

• Revalidation shall be performed at least once a year

CLEANROOM MAINTENANCE

• Collect all rubbish.

• Clean the floor using dust collector mop.

• Swab the laminar flow cabinet

• Cleaning is done before the office hour and at the end of the day

8 am 5 pm

Particle count during the day

CLEANROOM MAINTENANCE

CLEAN ROOM TESTING

•Air particulate count

•Air velocity / air changes

•Temperature

•Humidity

•Pressure differences

MICROBIOLOGICAL COUNTS

STERILITY TEST VERSUS MEDIA FILL

Sterility Test Media Fill

Guidance

Documents

FDA Guidance for Industry

Code of Federal Regulations

Multiple Pharmacopeia

FDA Guidance for Industry

EU Guide to Good

Manufacturing Practice

Revision to Annex 1

Sample size/Lot Maximum 40 All

Media Soybean-Casein Digest

Medium (TSB)

Fluid Thioglycollate Medium

(FTM)

Soybean-Casein Digest

Medium (TSB)

Incubation

conditions

TSB 14 days @ 20-25ºC

FTM 14 days @ 30-35ºC

TSB 7 days @ 20-25ºC

TSB 7 days @ 30-35ºC

Growth

promotion

Yes Yes

Test method Destructive:

Sample contents transferred

Non-destructive:

Integral container

Sensitivity False positives

Detects high level sterility

failure

No false positives

Detects single vial failure

DISPENSING

• All steps of preparation must be checked by qualified personnel

• Final products – after labelling must be counter check by Pharmacist /

Apoteker

• During collection – nurse must counter check the preparation”

• Right patients, right drugs, right dose, right route and right time on the

label

• Countercheck and initial on the receiving form

• During transportation medication must be place in the right container

• Proper storage before administration

DOCUMENTATION

• Prescription

• Sterility test and result

• Staff training

• Maintenance of equipments

• Record incidence of misadventures

• Storage and distribution record

• Handling of rejected and unfinished products

THANK YOUTERIMA KASIHMATUR NUWONHATUR NUHUNSALAMAT