QUALITY ASSURANCE DALAM ASEPTIC DISPENSING

FITRIANI MUTMAINAH
OUTLINE

RUANG LINGKUP PEMBELAJARAN

Rencana proses Penjaminan mutu terhadap

quality assurance proses pelayanan obat

FAKTOR –FAKTOR QA KESIMPULAN

TUJUAN PEMBELAJARAN
Setelah mengikuti materi ini,
peserta mampu melakukan
quality assurance dalam
pelayanan obat intravena
admixture

QUALITY ASSURANCE
Sistem prosedur, aktivitas, dan
pengawasan yang memastikan
bahwa proses compounding
secara konsisten memenuhi
standar kualitas.
PENGERTIAN
QUALITY CONTROL
Pengambilan sampel,
pengujian, dan dokumentasi
hasil yang, diambil bersama,
memastikan bahwa
spesifikasi telah dipenuhi
sebelum rilis CNSP.
VALIDASI/ VERIFY
Untuk memastikan bahwa
metode, proses, sistem, atau
peralatan akan bekerja
seperti yang diharapkan
dalam kondisi penggunaan
yang sebenarnya.
USP 797, 2019
 OUTCOME SEDIAAN STERIL
Mutu memenuhi standard

¨ Suatu kegiatan yang terukur dan STERIL

terpadu untuk memperoleh kualitas KOMPATIBEL

yang diharapkan, serta melakukan STABIL
perbaikan secara terus menerus
(Continually Quality Improvement/CQI) AMAN

dengan memperbaiki masalah, demi EFEKTIF

terwujudnya kepuasan pelanggan

¨ Program yang sistematis dalam
melakukan monitoring dan evaluasi
dari berbagai aspek pelayanan dan
fasilitas untuk menjamin kualitas HOW ??? TUJUAN
sesuai standar.
QUALITY
¨ Memberikan jaminan pada produk
ASSURANCE
 What can Affect Quality?

Drug

Procedures/
Work
QA/ Personnel
Processes Audit

Facilities &
Equipment
FAKTOR – FAKTOR YANG TERLIBAT

INPUT OUTPUT

• Writen policies, • End – product

guidelines, PROSES good quality OUTCOME
procedures • Micobiology test
• Clean room • Storage & Handling
within Pharmacy • Efficacy
• LAF/BSC • Patient Safety
• Protective • Aseptis dispensing
Appearel technique
• Personel training, • Process validation
education, • Handling procedures
evaluation • Labelling
• Health monitoring • Expiration dating
program • Documentation
KEBIJAKAN, PEDOMAN, PROSEDUR TERTULIS
• Up to date
• Available to all involved personnel
• Should be updated when changes occurs

1 STANDAR YANG DIGUNAKAN

2 PEDOMAN

OUTPUT
3 PANDUAN

4 PROSEDUR KERJA
CLEAN ROOM LAMINAR AIR FLOW APD

FASILITAS
OUTPUT
CLEAN ROOM
Ruang terkontrol partikel dan jumlah
mikroba
— Konstruksi khusus, dinding mudah
dibersihkan
— Tekanan udara diatur (lebih
positif)
— Suhu dan kelembaban terkontrol,
suhu 18ºC - 22ºC, kelembaban
30% - 70%
— Minimalkan adanya barang
— Tidak untuk lalu lintas orang
— Tidak boleh makan dan minum
 OUTPUT

LAMINAR AIR FLOW

• CLAS A/ 100
• TEKANAN POSITIF
• HORIZONTAL/ VERTIKAL
• HEPA
FASILITAS

¨ Validation 6-12 months

- DOP (HEPA Leak Test)
- Air velocity
- Smoke -Temp
-Microbiology
- Noise - KI disk
OUTPUT
(microbiological testing for
for operator
safety)
Personnel Education, Training & Evaluation
• Proper gowning &
gloving technique
• Mask
• Goggle
• Glove
• Gown

GMP: Good Manufacturing Practice

ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile Products

ASHP: American Society Of Health-System Pharmacists
TRAINING
INPUT
• Basic concepts of aseptic
technique
• Written and practical
training
• Clinical, Pharmaceutical &
Chemical drug properties
• Facilities, Equipment &
supplies
• IV Admixture process
Documentation

ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile

Products
ASHP: American Society Of Health-System Pharmacists
 Surface Environmental Sampling
Recommendation USP<797>2019
• Frequency:
- Initially
- At least every 6 months
§ Sample localizations:
- Working area of BSCs and CACIs
- Counter Tops (finished preparation)
- Areas adjacent to BSCs/ CACIs (Floor)

• If measurable level of - Patient administration areas

Contamination high : BSC: Biological Safety Cabinets
Identify cause of contamination CACI: Compounding Aseptic Containment Isolator
Document Contain
Retraining :Cleaning (high pH soap
& water )
Improving engineering controls
INPUT

USP United States Pharmacopeia. Pharmaceutical compounding sterile preparations (general chapter 797)
in: second supplement to UPS 31-NF 26: 2019
Environmental Control and Monitoring

¨ Evaluated by measuring the viable particles in the environment

¨ Count reported as colony forming unit (cfu) per cubic metre is a

measure of microbial contamination

¨ Air sampling carried out at least once a month using an air sampler set
for sampling 320 litres for 8 minutes

¨ Each sampling exercise must be carried out using two types of agar
strips/plates:
- TSA for total count at 30 – 35C for 48 hours
- Rose Bengal-Agar for yeast and mould 28 – 30C for 120hours

¨ If counts >1cfu per cubic metre no preparations to be done in that

cabinet
¨ Remedial actions to be carried out and cause of contamination traced

INPUT
Singapore Guidelines for Safe Handling of Cytotoxic Drugs
PRINSIP REKONSTITUSI
PROCESS
7 BENAR
BENAR PASIEN P
¨ Perhatikan sediaan obat BENAR OBAT P
harus baik, wadah
tidak pecah/terbuka, tidak BENAR DOSIS P
kadaluarsa. BENAR WAKTU P
BENAR CARA PEMBERIAN P
¨ Perhatikan keselamatan
pasien dengan mengurangi
medication error BENAR INFORMASI P
¨ Tehnik aseptis BENAR DOKUMENTASI P
¨ Tehnik tekanan negatif Waspada Efek Samping dan
Alergi
Seluruh permintaan rekonstitusi harus di cek
terlebih dahulu sebelum dilakukan rekonstitusi

PROCESS
•Identifikasi/profile pasien
• Dosis
• Kompatibilitas
• Stabilitas
•Persiapan/kelengkapan obat/alkes yang dipakai
 PROSES REKONSTITUSI
PROCESS

¨ PEMILIHAN SYRINGE DAN NEEDLE

¨ TEKNIK TEKANAN NEGATIF
¨ CLOSE SYSTEM DEVICE
¨ MIXING PROCESS
¨ DISOLVE PROCESS

Choice Of Device
Dependant on Degree of
Safety & Quality of Device
ISOPP Safe Handling
Standards: Must Be Air
Tight & LeakProof
 LABELING PROCESS

• Patient name and identification

• Batch no if batch prepared
• All solution & ingredient names,
amounts,strengths & concentrations
• Expiration date ( and time when
applicable)
• Volume of regimen, flow rate and route
• Appropriate auxiliary labeling
• Storage requirements
• Identification of pharmacist/staff in charge
• Contact numbers

ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile Products

ASHP: American Society Of Health-System Pharmacists
 PROCESS
EXPIRE DATING
• Patient name and identification
• Batch no if batch prepared
• All solution & ingredient names,
amounts,strengths & concentrations
• Expiration date ( and time when
applicable)
• Volume of regimen, flow rate and route
• Appropriate auxiliary labeling
• Storage requirements
• Identification of pharmacist/staff in charge
• Contact numbers

ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile Products

ASHP: American Society Of Health-System Pharmacists
 Dokumentasi
Staf : PROCESS
¢ Hasil pemeriksaan kesehatan
¢ Keterpaparan obat kanker
¢ Pendidikan dan pelatihan
¢ Validasi
Fasilitas
¢ Hasil pemeriksaan mikrobiologi ruangan dan BSC
¢ Data pemeliharaan dan kalibrasi
¢ Data perbedaan tekanan
¢ Data suhu dan kelembaban
¢ Perhitungan jumlah partikel (fungsi HEPA)
¢ Hasil validasi ruang clean room dan BSC
Formulir perhitungan dosis dan rekonstitusi
Laporan insiden tumpahan, kecelakaan kerja & Ekstravasasi
RCA (Root Cause Analysis) jika terjadi insiden
Pembersihan Clean room dan BSC
Data beban kerja setiap petugas
Prosedur
MSDS
END PRODUCT EVOLUTION OUTPUT

• container leaks
• container integrity
• solution cloudiness
• particulates in the solution
• appropriate solution colour
• solution volume when preparation is
completed
• verification that product was
reconstituted accurately

ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile Products

ASHP: American Society Of Health-System Pharmacists
 Microbiological Monitoring
OUTPUT

Premises
n

n environmental monitoring
n cleaning and disinfection
Product : sampling
n

People
n

n operator broth transfer tests

n hand cleaning and disinfection
¨Validasi Produk
- Uji mikrobiologi 6 bulan sekali (clean room, BSC, produk
akhir.)
¨Validasi clean room : minimal 1 x setahun
¨Validasi alat
- Pemeliharaan dan kalibrasi BSC 6 - 12 bulan sekali
- Kalibrasi fungsi HEPA : DOP, Smoke test, noise,
temperatur, air velocity, KI Disk
¨Validasi :
- petugas : pengetahuan dan tehnik aseptis.
- Proses : kesesuaian SOP, dan tehnik aseptis

OUTPUT
 Conclusion
- The pharmacy should have written policies and
procedures which is
- available to all personnel involved in cytotoxic drug preparation
- important for personnel to understand before being allowed to
prepare cytotoxic preparations
- allows personnel competency to be assessed periodically

- Standards of Practice for Safe Handling of Cytotoxic

Agents is a powerful instrument. ISOPP can be use
because of its global acceptance and distribution.
- The audit tool completes the standards and helps the
hospital to evaluate and progress.
Terima Kasih