TEKNIK ASEPTIK DISPENSING &

PENCAMPURAN OBAT IV

A P T. R I S AY U N U A R I , M . FA R M
DEFINISI
 Aseptic Dispensing adalah salah satu metode untuk meminimalisir
sediaan farmasi dari bahaya pirogen dan kontaminan. Metode ini
meliputi tahap penyiapan, pencampuran, penyimpanan, dan
pembuangan. Setiap tahap erat kaitannya dengan ketersediaan
sumber daya manusia, peralatan, ruang.
 Steril adalah kondisi sediaan yang terbebas dari partikel asing non
self, tidak terdapat/ tercemar mikroorganisme.
 Parenteral merupakan jalur dimana obat dimasukkan ke dalam
tubuh pasien menggunakan jarum suntik. Ada empat rute parenteral
yang umum digunakan, yaitu : intradermal (ID), subkutan (SC),
intramuskular (IM), dan intravena (IV)
PENGGUNAAN SEDIAAN PARENTERAL

 NPO (Nothing by Mouth)

 Untstable in GI, 1st pass metabolism
 Immediate Action Needed
 Delivery to Spesific Site
 Depot Form
 LVP (large volume parenteral) (>100 ml)
 “piggy back” smaller volume (may be up to 250 ml)
 D5W (5% dextrose in water)
 NS (normal saline) 0,9% NaCl
 CSP ( Coumponded sterile preparation)
 Continuous infusion vs intermittent dosing
 HEPA filter – High Efficiency Particulate Air
 ISO : International Organization for Standardization
LAMINAR AIR FLOW
PROSEDUR KERJA LAMINAR AIR FLOW

1. Nyalakan lampu Uv minimal 30 menit, sebelum laminar air

flow digunakan.
2. Siapkan semua alat-alat steril yg akan dipergunakan. Alat-alat
yang dimasukkan kedalam laminar air flow cabinet, disemprot
terlebih dahulu dengan menggunakan alkohol 70 % atau
spiritus.
3. Meja dan dinding dalam LAF disemprot dengan alkohol 70%
atau dg spiritus untuk mensterilakan LAF.
4. Blower pada LAF dihidupkan untuk menjalankan air folow
5. Nyalakan lampu dalam LAF
6. LAF sudah siap untuk digunakan.
 BUFFER ROOM
RUANG STERIL YANG DIGUNAKAN UNTUK TEKNIK
ASEPTIK

 Must be ISO Class 7 (Class 10,000)

 Prepared in a ISO Class 5 (Class 100) Laminar airflow
workbench
 Positive pressure room with HEPA filtered air
 Access is restricted in Buffer area

 Walls, Floors, ceiling should be smooth, no cracks and crevices

 Ceiling should be sealed
 Floors coved
 No sinks in buffer area
 Only non shedding paper products in area
 ANTE ROOM
RUANG STERIL YANG DIGUNAKAN UNTUK
TEKNIK ASEPTIK

• Gowning and hand-washing

• No food or bevarages
• No carts moving back and forth from buffer zone to ante –area
• Wipe down of products before introducing into the buffer area
 GOWNING
PAKAIAN YANG DIGUNAKAN PADA SAAT TEKNIK ASEPTIK

• Remove make up, jewelry

• Scrub hands and arms to elbow
• Non shedding gown, knee length with a zip or snap front
• Sho covers, hair covers, face mask, and gloves
 RISK CLASIFICATION

Low Risk compounding Simple admixtures using closed

system transfer methods

Medium Risk Coumpounding Admixtures using multiple additives

or batch preparations

High Risk Coumpounding Non-sterile ingredients or open

system transfers.
 BEYOND USE DATING (BUD)
Storage period before administration.
When compounded sterile products are stored for prolonged
Periods of time there is potential for microbial growth and pyrogen
formation.
Chemical stability
Microbial sterility

Risk Level Room Temp Refrigeration Freezer

Low 48 hrs 14 days 45 days

Medium 30 hrs 9 days 45 days

High 24 hrs 3 dats 45 days

SYRING/ SPUIT /SUNTIKAN

• Parts of syringe
Barrel
Scale
Plunger Seal
Tip /adaptor
• Parts of needle
Bevel
Shaft
Hub/adaptor
 TECHNIC ASEPTIK DISPENSING
TAHAPAN TEKNIK ASEPTIK

• Preparation
Calculations based on Prescription
Assembly
APD
• Cleaning
• Inspection I
Expriration dates
Quality
• Inspection II
Quality
PENCAMPURAN OBAT INTRAVENA
DEFINISI
• “admixture system” refers to sterile IV solutions that are prepared by using one
or more medications or electrolytes and will be administered via the parenteral
route.
• It requires the measured addition of a medication to a 50 ml or larger bag or
bottle of IV fluid
• It can be provided to the patient in his/ her home
• Many hospitals involved in compounding Ivvsolutions and medications to out
patient settings.
ROLE OF PHARMACIST

Parenteral
drugs
experts

Coumpound Administer Monitor

parentelal parenteral parenteral
solutions solutions solutions

compatibilit
stability
y
 RESPONSIBILITIES OF PHARMACIST

 Contamination : The pharmacy must maintain a clean area out of

the direct flow of traffic with a vertical or horizontal laminar air
flow hood to prepare IV admixtures.

 Compatibility : A pharmacist should be able to deal with

problems of physical, chemical, and theapeutic incompatibilities. To
design suitable alternatives when these problem arise.
 RESPONSIBILITIES OF PHARMACIST

Stability

• Drug stability information must be readily accessible to the

pharmacist in order to deter mine optimum conditionsfor drug
storage prior and after prepatation.
• The stability of a drug at ideal storage conditions will help to
establish a reasonable expiration date for the product.
• Product sterility, overall integrity also inspected.
 Preparation
area

Admixture
Storage area
systems
System
component

Policies and
Personal
procedures
 PREPARATION

 Ideally a separate room in pharmacy

 Size may vary
 Requerements of room :
 Washable floor covered with vinyl or epoxy coating
 Hand washing facility
 Refrigerator
 Preparation Tools
 Adequate light
 Restricted area
 Adequate Counter Space
 POLICIES & PROSCEDURE

 Auxiliary label
 Required to avoid fatal errors
 These include :
• Note dosage strength
• Protect from light
• Do not refrigerate
• Caution : chemotherapeutic
• For epidural use only
 PERSONNEL

 Proper training in Aseptic technique and sterile product

information is necessary
 Training courses, self study programs can be organized for this
purpose.
 Training can be of varying levels (regular, intense or module
based)
 Job description for each of the personnel should be well defined
(who will do what?)
STORAGE
 Will depend on the type of system one chooses to use
 There should be proper refrigeration facility available.
 INCOMPATIBILITIES

 Physical Incompatibilities
 Chemical Incompatibilities
 Therapeutic Incimpatibilities
 Drug IV container Incompatibilities
 RESUME
• Periksa resep dan petunjuk pada resep
• Siapkan obat, syringe, needle, pelarut, handscoon, APD, pelarut yang compatible
• Cuci tangan 6 langkah, dan kenakan APD
• Lakukan pada ruang /tempat khusus yg telah dibersihkan
• Buka vial / ampul dengan hati-hati (tangan sudah menggunakan handscoon),
siapkan syringe dan needle tanpa menyentuh critical tip (menjaga tetap steril)
• Usap tutup vial dengan alcohol swab
• Ambil pelarut dengan vial di atas dan syringe dibawah (sebelumnya syringe diisi
udara agar cairan dpt masuk ke syringe) begitu juga pada saat mengambil obat
lainnya.
• Masukkan pelarut kedalam vial yang berisi obat, usahakan melalui dinding vial
bagian dalam (agar tidak berbuih)
• Lalu goyangkan vial perlahan agar obat tercampur dengan pelarut
• Tempelkan label identitas pasien, BUD,komposisi, dan tutup vial. Periksa
kembali
 RESUME

• Periksa label pada kemasan, identitas pasien

• Cuci tangan 6 langkah, gunakan handscoon
• Buka penutup needle (jaringan menyentuh critical tip),
usapkan alcohol swab pada port atau kulit.
• Gunakan obat sesuai intruksi pada resep
• Catat penggunaan obat
• Buang syringe dan needle pada safety box.
SOAL

Dokter meresepkan Cefazolin Sodium 0,25 g. IM q.8h, Farmasi

memberikan 1 vial Cefazolin Sodium sterile Powdered 1g, dengan
instruksi “untuk IM, add 2,5 ml sterile water for injection & shake.
Vol 3 ml (330 mg/ml)
1. Berapa volume pelarut yang ditambahkan
2. Pelarut apa yang ditambahkan?
3. Berapa kekuatan dosis Cefazolin tersebut?
4. Berapa volume obat yang diberikan ke pasien?
JAWABAN

1. 2,5 ml
2. Sterile water for injection
3. 330 mg/ ml
4. 1000 mg/ 3ml = 250 mg / x (ml)
X(ml) = 250 mg x 3 /1000 mg
X (ml) =0,75 ml