Teknologi Sediaan Farmasi -

Steril
Dewi Rahma Fitri, M.Farm., Apt

Institut Sains & Teknologi Al-Kamal

Genap 2021/2022
Syllabus
• Introduction to sterile formulation (5W1H and
preformulation)
• Room, air circulation and other specification aspect
to sterile formulation
• Types of sterile formulations (emphasized on
parenteral route)
• Excipients of sterile formulations (emphasized on
WFI)
• Calculation of sterile formulations (isotonicity,
osmolarity, etc)
• Sterilisation and pyrogenicity method
• Testing of sterility and pyrogenicity
Target of achieved learning
• Students understand the meaning of sterile
products/formulation
• Students understand preformulation concept of
sterile products
• Students understand important aspects to sterile
formulation
• Students understand additive substances and vehicles
used in sterile formulations
• Students understand how to formulate and calculate
sterile liquid formulation
• Students understand the importance of sterilization
and its testing to ensure the quality of sterile products
Literature
• Aulton, M.E. 1994, Pharmaceutics, The Science of Dosage
Forms Design, ELBS., Edinburg
• Banker, G.S. and Rhodes, C.T. 2002, Modern Pharmaceutics,
4th Ed., Marcel Dekker Inc., New York.
• Gennaro, A.R. 2001, Remington: The Science and Practice of
Pharmacy 20th edition, Lippincott Williams & Wilkins,
Philadelphia
• Lachmann, L., Liebermann, H. dan Kanig, J. 1987, The
Theory and Practice of Indutrial Pharmacy, Lea and
Febigher, Philadelphia
• Lukas, S. 2006, Formulasi Steril edisi revisi, Penerbit Andi,
Yogyakarta
Pertemuan 1
Introduction
 What is sterile
product? ?

Dosage forms of therapeutic agents that are free of

viable organisms (including pyrogenic substances) ,
which intended usage are applied through the skin or
mucous membrane.
Why the need for How are the
sterile products process carried out

Where do we When do we use

manufacture them sterile products

Who creates the

concept of sterile
product
Sterile products
• Injection
• Large Volume Parenterals (LVP)
• Irrigation solutions
• Ophthalmic products (solution, cream)
• Otic products (viscous solution, suspension)
• Nasal products (spray solution, suspension)
• Implant

Medical devices
• Injection needle and syringe
• Sterile gauze
• Suture
Preformulation
Why
preformulation is
needed?

Ensuring the
Concept of quality
quality of product
Preformulation
 Most important
aspect to consider? ?

Solubility and stability

Ex: Crystal Characteristics

Increase in density of crystal 🡪increase of dissolution rate

 Adherence to procedures is important in
creating crystalline structures

Wrong decision making in substitutes may

destroy the products

Ex: usage of absolute ethanol instead of

95% ethanol for hydrate crystals formation
Humidity effect on stability of hydrate crystalline form
Objective of Sterile products
• Similar to other pharmaceutical products 🡪To

elicit efficacy

• How?

Biopharmaceutics Route of
consideration administration
Nature of preparation
• Intravena, intraspinal 🡪aqueous solution

• Intramuscular, subcutaneous 🡪solution,

suspension, emulsion. Vehicle can be more
varietive

• Type and route of administration can influence

therapeutic onset, duration of effect