Sterile Dosage Forms & Biologics Flashcards by Natasha Pauline Roque

Means the destruction of all living organisms and their spores or their complete removal from any preparation

sterilization

How well did you know this?

Not at all

Perfectly

Steam under pressure in an autoclave

Steam/Moist Heat Sterilization

How well did you know this?

Not at all

Perfectly

MOA of Steam/Moist Heat Sterilization

Denaturation and coagulation

How well did you know this?

Not at all

Perfectly

p, time, and temp required for Steam/Moist Heat Sterilization

10 lb pressure for 30 mins → 115.5 C
15 lb pressure for 20 mins →121.5 C
20 lb pressure for 15 mins →126.5 C

How well did you know this?

Not at all

Perfectly

commonly used for moist heat sterilization

Autoclave

How well did you know this?

Not at all

Perfectly

heat-stable materials used for Moist heat Sterilization

Bulk solutions
Glassware
Medical devices
Surgical dressings
Not for oils, fats, oleaginous preparations

How well did you know this?

Not at all

Perfectly

Dehydration followed by slow oxidation

Dry Heat Sterilization

How well did you know this?

Not at all

Perfectly

temperature and time required for Dry Heat Sterilization

160°C for 120 minutes
150-170°C for not less than 2 hours

How well did you know this?

Not at all

Perfectly

heat-stable materials which cannot be sterilized by moist heat

Fixed oils, glycerin, various petroleum products,
Glassware
Medical devices, instruments

How well did you know this?

Not at all

Perfectly

Non-thermal method based on the removal of microorganisms by adsorption on filter medium

Sterilization by Filtration

How well did you know this?

Not at all

Perfectly

Millipore filter

14 to 0.025 um

How well did you know this?

Not at all

Perfectly

RBC Millipore filter

6.5 um

How well did you know this?

Not at all

Perfectly

smallest bacteria Millipore filter

0.2 um

How well did you know this?

Not at all

Perfectly

poliovirus Millipore filter

0.025 um

How well did you know this?

Not at all

Perfectly

usually consist of fritted glass or unglazed porcelain-substances that trap particles in channels.

Depth filter

How well did you know this?

Not at all

Perfectly

Particulate filter remove particles of glass, plastic, rubber, and other contaminants

Screen filter

How well did you know this?

Not at all

Perfectly

which may be either particulate or microbial, are in-line filters used to remove particulates or microorganisms from an intravenous solution before infusion

Final Filter

How well did you know this?

Not at all

Perfectly

filter for Cellulosic materials (acetate, nitrates, fluorocarbonate, acrylic polymers, polyester, PVC, vinyl, nylon, polytef)

Membrane filter

How well did you know this?

Not at all

Perfectly

examples of cellulosic materials

acetate, nitrates, fluorocarbonate, acrylic polymers, polyester, PVC, vinyl, nylon, polytef

How well did you know this?

Not at all

Perfectly

In this method, ethylene oxide is generally used in combination with heat and moisture

Gas Sterilization

How well did you know this?

Not at all

Perfectly

used to sterilize surfaces and porous materials (e.g., surgical dressings) that other sterilization methods may damage.

Gas Sterilization

How well did you know this?

Not at all

Perfectly

Gas Sterilization is Affected by

time, temperature, gas concentration, humidity

How well did you know this?

Not at all

Perfectly

is suitable for the industrial sterilization of contents in sealed packages that cannot be exposed to heat (e.g., prepackaged surgical components and some ophthalmic ointments).

Radioactive sterilization

How well did you know this?

Not at all

Perfectly

This technique involves irradiation causing cellular destruction

Radioactive sterilization

How well did you know this?

Not at all

Perfectly

Radioactive sterilization sometimes results

Accelerated drug decomposition

Media fills is that the growth medium will support the growth of the contaminating microbe, and this growth can be detected.

Validation of sterility

bacteria used for steam and gas sterilization

B. stearothermophilus

bacteria used for dry heat

B. subtilis

bacteria used for membrane filtration

P. diminuta

Time required to kill a particular organism under specified conditions

Thermal death time

e lipid substances associated with a carrier molecule, which is usually a polysaccharide but maybe a protein.

Pyrogen

are fever-producing organic metabolic products arising from microbial contamination and responsible for many of the febrile reactions in patients following injection

Pyrogen

Pyrogen is aka

bacterial endotoxins

This is a test for estimating the concentration of bacterial endotoxins

Bacterial Endotoxin Test

Endotoxins react with enzyme __forming gel-clot formation

Limulus Amebocyte Lysate (LAL)

LAL are obtained from aqueous extracts of the circulating amebocytes of the

horseshoe crab, Limulus polyphemus

General Process of parenteral production

procurement and selection of the components production facilities and procedure quality control packaging handling

is used to remove particles from solutions.

Filtration

sealed glass containers with an elongated neck that must be broken off.

Ampules

Types of Ampule

Pull seal Tip seal

are made of glass or plastic and are sealed with a rubber stopper.

Vials

A cartridge-type package

Prefilled syringes

Ready-to-mix systems

Mix – O – Vial (Pharmacia) Example: Solu-Medrol ADD Vantage System (Abbott)

can be defined as the sum total of methods and manipulations required to minimize the contamination of sterile compounded formulations.

Aseptic technique

The USP provides two basic methods of Sterility Test

direct introduction method membrane filtration method.

is a quantitative fever response test in rabbits.

Pyrogen testing

is a tube that is open at one end and tapers into a hollow tip at the other end.

barrel

is a piston-type rod with a slightly cone-shaped top that passes inside the barrel of the syringe.

plunger

provides the point of attachment for a needle

tip

secure screw type connection

luer lok tip

slip or push-on connection

slip tip

off center tip used for surface veins or artery injections

eccentric tip

longer and tapered slip tip used for irrigation or with tubing

catheter tip

The set contains a spiked plastic device to pierce a port on the IV container

IV Infusion Pumps

This connects to a sight or drip chamber that may be used to set the flow rate

IV Infusion Pumps

is a short piece of tubing attached to a needle or intravenous catheter

Heparin lock

separation of substances from one another in solution by taking advantage of their differing diffusibility through membrane

Dialysis

It is now known that prolonged exposure to these agents may lead to the development of cancers.

Cytotoxic Agents

These agents also represent an environmental hazard and must be handled carefully.

Radiopharmaceuticals

These agents should be prepared in a shielded vertical flow hood, so that materials are not blown into the operators face

Cytotoxic Agents

it is desirable to work with them in a shielded vertical flow hood to avoid environmental contamination.

Antibiotics

are substance derived from a living organism and used for the prevention or treatment of disease

Biologicals

include antitoxins, bacterial and viral vaccines, blood products and hormone extracts.

Biologicals

any virus, therapeutic serum, toxin, antitoxin, or analogous product employed for prevention, treatment, or cure of diseases in humans (Code of Federal Regulations)

Biologicals

State of relative resistance to a disease that develops after exposure to the specific diseasecausing agent

Immunity

Also known as innate or native immunity

Natural Immunity

is the process by which an individual is exposed to an agent that is designed to fortify his or her immune system against that agent.

Immunization

originated vaccination procedure

Edward Jenner

defined a chemical nutrient medium in which cells can grow and replicate

Dr. Raymond Parker

developed polio vaccine

Jonas Salk

vaccine that was developed few years later

Sabin polio vaccine

Substance used to produced immunization

Vaccines

it refers to the use of a biologic product (a vaccine) to develop active immunity in the patient.

Vaccination

is where the actual microbe is taken in by a person. Antibodies are created by the recipient and are stored permanently

Active immunization

when an untreated microbe is received by a person who has not yet come into contact with the microbe and has no pre-made antibodies for defense.

Natural active immunization

where the treated microbe is injected into the person before they are able to take it in naturally

Artificial active immunizationv

is where pre-made antibodies are given to a person.

Passive immunization

when antibodies are being transferred from mother to fetus during pregnancy, to help protect the fetus before and shortly after birth

Natural passive immunization

given by injection and is used if there has been a recent outbreak of a particular disease or as an emergency treatment to poisons.

Artificial passive immunization

contain bacteria or viruses that have been altered so they can't cause disease

Live attenuated vaccines

contain killed bacteria or inactivated viruses.

Killed vaccines

contain toxins (or poisons) produced by the germ that have been made harmless.

Toxoid vaccines

contain parts of the whole bacteria or viruses.

Component vaccines

usually are created from the naturally occurring germ itself.

Live attenuated vaccines

Viruses are weakened by growing them over and over again in a laboratory under nourishing conditions called cell culture.

Live attenuated vaccines

Examples of live attenuated vaccines include:

Measles vaccine (as found in the MMR vaccine) Mumps vaccine (MMR vaccine) Rubella (German measles) vaccine ( MMR vaccine) Oral polio vaccine (OPV) Varicella (chickenpox) vaccine

cannot cause an infection, but they still can stimulate a protective immune response.

Inactivated (killed) vaccines

Viruses are inactivated with chemicals such as

formaldehyde

Examples of Inactivated (killed) vaccines

Inactivated polio vaccine (IPV), which is the shot form of the polio vaccine Inactivated influenza vaccine

shot form of the polio vaccine

Inactivated polio vaccine (IPV)

made by treating toxins produced by germs with heat or chemicals, such as formalin, to destroy their ability to cause illness.

Toxoid vaccines

toxoids vaccines are made by treating toxins produced by germs with heat or chemicals, such as

formalin

do not cause disease but they stimulate the body to produce protective immunity just like the germs' natural toxins.

Toxoid vaccines

examples of Toxoid vaccines

Diphtheria toxoid vaccine Tetanus toxoid vaccine

made by using only parts of the viruses or bacteria

Component vaccines

Examples of component vaccines:

Haemophilus influenzae type B (Hib) vaccine Hepatitis B (Hep B) vaccine Hepatitis A (Hep A) vaccine Pneumoccocal conjugate vaccine

Production consists of

Extraction Chemical synthesis GENETIC ENGINEERING

is the artificial alteration of the genetic composition of cells or organisms.

Genetic engineering

is fundamental to genetic engineering.

Gene cloning

is the common preservative

Thimerosal (49.6%)