WEBINAR HISFARSI

PD IAI SUMUT

FASILITAS &
MAINTENANCE
Aseptic Dispensing

17 Oktober 2021
Eko Fransiska
EKO FRANSISKA

DEPO SITOSTATIKA
RSUP DR KARIADI
SEMARANG
Agenda
 Guideline Standar Penyiapan Sediaan
Steril

 Ruang Lingkup

 Persyaratan Fasilitas
 Cleanroom
 BSC/ LAFC

 Maintenance

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GUIDELINE STANDAR PENYIAPAN SEDIAAN
STERIL
• UU No 44 Tahun 2009 tentang Rumah Sakit : Rumah Sakit harus
memenuhi persyaratan lokasi, bangunan, prasarana, sumber
daya manusia, kefarmasian, dan peralatan
• PMK No 72 Tahun 2016 tentang Standar Pelayanan Kefarmasian
di RSDispensing sediaan steril harus dilakukan di Instalasi
Farmasi dengan teknik aseptik untuk menjamin sterilitas dan
stabilitas produk dan melindungi petugas dari paparan zat
berbahaya serta menghindari terjadinya kesalahan pemberian
Obat.

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 PMK No 72 Tahun 2016 
• Faktor-faktor yang perlu diperhatikan pada pencampuran obat suntik :
1) ruangan khusus;
2) lemari pencampuran Biological Safety Cabinet;
3) HEPA Filter.
• Faktor-faktor yang perlu diperhatikan pada penyiapan nutrisi parentera
1) tim yang terdiri dari dokter, Apoteker, perawat, ahli gizi;
2) sarana dan peralatan;
3) ruangan khusus;
4) lemari pencampuran Biological Safety Cabinet; dan
5) kantong khusus untuk nutrisi parenteral.

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Guidelines
 USP General Chapter <797> Pharmaceutical
Compounding—Sterile Preparations

 USP <800> Hazardous Drugs─Handling in Healthcare

Settings

 PIC/S Guideline

 ASHP Guidelines on Compounding Sterile Preparations

 ISOPP Standards of Practice Safe Handling of Cytotoxics

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• To provide minimum practice and quality standards for compounded sterile preparations (CSPs)
based on current scientific information and best sterile compounding practices
• To describe conditions and practices to prevent harm, including death, to patients that could
result from
(1) microbial contamination (nonsterility)
(2) excessive bacterial endotoxins
(3) variability in the intended strength of correct ingredients that exceeds either monograph
limits for official articles or 10% for nonofficial articles Contaminants of concern include:
(4) unintended chemical and physical contaminants • Bacteria
• Fungus
(5) ingredients of inappropriate quality in CSPs • Pyrogens
• Particulate matter
• Allergens
• Drug residues

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RUANG LINGKUP
Why compound
 Meet the needs of patients

 Evidence-based

 Appropriate

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Type of CSP
 Large volume parenterals

 Small volume parenterals

 Piggyback bags

 Syringes

 Irrigations

 Ophthalmics

 Parenteral nutrition (PN)

 Inhalations

 Allergen extracts

 Hazardous Drugs & Radiopharmaceutical

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 Mitigasi Resiko
 Review the NIOSH list
 Identify the drugs and dosage forms handled by the facility
 Determine your approach
Option 1
Treat all dosage forms of all HDs the same

Option 2
Perform an Assessment of Risk
Identify and use alternative containment strategies and/or work
practices for specific dosage forms of HDs that are not antineoplastic
agents or are not APIs
PERSYARATAN FASILITAS
 Prinsip & Tujuan Sterile
Cytotoxic Preparation

BSC

Ruangan
Teknik Aseptis

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Engineering Control

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Kasifikasi Ruang

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Kasifikasi Ruang

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Kasifikasi Ruang

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Sumber partikel

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 Fasilities Option (PIC/S)

Background Environmen For BSC/ LFC Background Environmen For Isolator Shelf Life
Class B Class D > 24 hour
Class D Class D < 24 hour

Isolator Pressure Background Environment

Negative Pressure Grade C (ISO 7)
Positive Pressure Grade D (ISO 8)

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Fasilities Option (USP)
• ISO Class 5 PEC
• Buffer Area ISO class 7
Cleanroom Suite • Anteroom
• Low Risk Contaminant Level

Segregated • ISO Class 5 PEC

• Unclassified Space
Compounding • No Anteroom
• Low-Risk Contaminant Level with 12-hour or less
Area

• Immediate Use
• Not for HD
Ambient Air
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CLEANROOM
“A Cleanroom is "a room in 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.“
ISO14644-1, British Standard

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BSC/ LAFC
Classes

Cabinet

Isolator BSC Chemical

Clean Bench Fume Hood

Class III Class II Class I

Horisontal Vertical
Type Type Type Type Laminar Laminar
B2 B1 A3 A1 Cabinet Cabinet
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 Protection
Type Of Cabinet Personel Product Evironment
Protection Protection Protection
Chemical Fume +
Hood
Clean Bench +
BSC Class I + +
BSC Class II + + +
BSC Class III + + +
Isolator + + +
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 ‘‘LFCs are not suitable for the
preparation of hazardous
drugs. Biohazard safety
cabinets (BSCs) should be used
instead, with a vertical down
flow exhausting vertically from
the cabinet and not towards
the operator.’’
PIC/S
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 BSC Kelas II Tipe A1 BSC Kelas II Tipe A2
Type A1 BSCs are not suitable for use with volatile toxic If these cabinets are used for minute quantities of volatile
chemicals and volatile radionuclides toxic chemicals and trace amounts of radionu-clides, they
must be exhausted through properly functioning exhaust
canopies
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 BSC Kelas II Tipe B1 BSC Kelas II Tipe B2
If these cabinets are used for work involving minute quantities These cabinets may be used with volatile toxic chemicals
of volatile toxic chemicals and trace amounts of radionu-clides, and radionuclides
the work must be done in the directly exhausted portion of the
cabinet
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• Closed-system
• Udara keluar disaring dua kali dengan menggunakan
filter HEPA dan diinsinerasi
 Tekanan
Closed System Sterilisasi
Negatif
More Simple
Ruang C/ D Chamber
Maintenance
“The definitions isolator and
BSC Class III may overlap if
Class III BSC is sterilized and
provides an uncompromised
and continuous isolation by
the use of special transfer
systems”

ISOPP
CDSC?

Perbedaannya hanya pada penambahan

carbon filter pada exhaust HEPA filternya

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 “Some countries, for example, Australia, require
the inclusion of an activated carbon filter fitted
downstream of the exhaust HEPA filter to counter
the problem of cytotoxic drugs which may
vapourise and pass through the HEPA exhaust
filter. However, concerns exist over the
effectiveness of activated carbon in removal of
these volatile substances. These filters absorb
vapour in a dynamic equilibrium with the
surroundings. Potentially, if the concentration of
the drug in the environment drops, the drug may
be released from the filter. Australian Standard
AS2567–1 suggests that the minimum mass of
activated charcoal must be 28 g/l/s of airflow.”

ISOPP
MAINTENANCE
Maintenance
Cleaning Parameter Monitoring Environmental Monitoring
 Daily  Suhu  per hari  Non Viable (Particle Count)
 Weekly  minimal 6 bulan
 Kelembaban  per hari
 Monthly  Viable (Microbiological Test)
 Perbedaan Tekanan  per
• Air Sampling  6 bulan
 Room & BSC hari
• Surface Sampling  Periodically
 Prosedur  Pertukaran Udara  6 bulan
 Filtrasi Udara (Integrity Test
HEPA Filter)  6 bulan (USP)
 Kalibrasi BSC/ LAFC  6
bulan (USP)

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SALAM SEHAT SELALU

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