1
Q
a dosage form that is FREE form contaminating microorganisms
A
STERILE PRODUCT
2
Q
- they are defined as sterile, pyrogen-free preparations intended to be administered parenterally
A
INJECTIONS/INJECTABLES
3
Q
- are fever producing organic substances arising from microbial contamination and are responsible for many of the febrile reactions
A
PYROGENS
4
Q
- these injectables are packaged in SMALL ampoules or vials, with fill volumes of as little as 0.5mL to a maximum of 50mL
A
SMALL VOLUME PARENTERALS
5
Q
SMALL VOLUME PARENTERALS:
* cardiac and respiratory stimulants
A
Caffeine & Sodium benzoate injection
6
Q
SMALL VOLUME PARENTERALS:
* local anesthetic
A
Procaine hydrochloride injection
7
Q
SMALL VOLUME PARENTERALS:
* for diabetes
A
insulin injection
8
Q
- these injectables are packaged in collapsible bags or 1 liter size vials
- they are administered in volumes of 100-1,000mL amounts and more per day, by small IV drip sets with or without controlled rate infusion system
A
LARGE VOLUME PARENTERALS
9
Q
LARGE VOLUME PARENTERALS ARE EMPLOYED FOR:
- for patients entering or recovering from surgery
- for patients who are unconscious and unable to obtain fluids, electroyltes, or nutrition orally
A
MAINTENANCE THERAPY
10
Q
LARGE VOLUME PARENTERALS ARE EMPLOYED FOR:
- for patients who have suffered a great loss of fluids & electrolytes, as in severe diarrhea and vomiting or in the replenishment of blood
A
REPLACEMENT THERAPY
11
Q
LARGE VOLUME PARENTERALS ARE EMPLOYED FOR:
REPLACEMENT THERAPY:
* diuretic
A
Minimal injection, USP
12
Q
LARGE VOLUME PARENTERALS ARE EMPLOYED FOR:
REPLACEMENT THERAPY:
* systemic alkalinizer
A
Lactated Ringer’s injection, USP
13
Q
LARGE VOLUME PARENTERALS ARE EMPLOYED FOR:
REPLACEMENT THERAPY:
* fluid, nutrient, electrolyte replenisher
A
Dextorse & Sodium chloride injection, USP
14
Q
LARGE VOLUME PARENTERALS ARE EMPLOYED FOR:
REPLACEMENT THERAPY:
* isotonic vehicle
A
Sodium Chloride injection, USP
15
Q
VEHICLES TO BE USED
- the most frequently used vehicle since it is the vehicle for all natural body fluids
A
WATER
16
Q
VEHICLES TO BE USED
the superior quality requirements is described under ____
A
water for injection, USP
17
Q
VEHICLES TO BE USED
USP SPECIFICATIONS FOR FIXED OILS
A
- must be vegetable origin
- remain liquid at room temp
- not become rancid rapidly
18
Q
SOURCES OF PYROGEN
A
water
equipment
solutes
manufacturing methods
19
Q
PYROGENS CAN BE DESTROYED….
DRY-HEATING SETTINGS:
* for 45 minutes
A
240 - 250C
20
Q
PYROGENS CAN BE DESTROYED….
DRY HEATING SETTINGS:
* for 1 minute
A
650C
21
Q
PYROGENS CAN BE DESTROYED….
DRY HEATING SETTINGS:
* for 4 hours
A
180C
22
Q
PYROGENS CAN BE DESTROYED….
this will NOT destroy pyrogens
A
autoclaving
23
Q
GLASS CONTAINERS
- generally suitable for ALL parenterals
A
TYPE I
Borosilicate glass
24
Q
GLASS CONTAINERS
- treated with Sulfur dioxide
- suitable for parenteral solutions which are buffered, with pH below 7, and not reactive with glass
A
TYPE II
Soda lime glass
25
# **GLASS CONTAINERS**
* suitable for **ANHYDROUS** parenteral liquids or **dry substances**
TYPE III
Regular Soda lime glass
26
# **GLASS CONTAINERS**
* **NOT** for parenteral use
* suitable only for **extractives**
TYPE NP
27
# **PLASTIC CONTAINERS**
* makes it possible to **squeeze the side walls** of the container to discharge one or more drops, **without the introduction of contaminants** into the remaining contents of the container
* used for **small volume** only
LD PET
Low density Polyethylene Terephthalate
28
# **PLASTIC CONTAINERS**
* used for **large volume parenterals**
* there is **NO air interchange**
* the bag simply **collapses** as the solution flow out the bag
PVS or select POLYOLEFINS
29
* process of **removal of water** from the parenteral solution, by **SUBLIMATION**, after it is frozen
* this process is only applicable to **thermo-labile** or **unstable drugs in aqueous, liquid form**
FREEZE-DRIED / LYOPHILIZED
30
# **ROUTE OF ADMINISTRATION**
**INTRA**CUTANEOUS
NMT 0.2mL due to slow absorption
31
# **ROUTE OF ADMINISTRATION**
**SUB**CUTANEOUS
about 1mL or less
32
# **ROUTE OF ADMINISTRATION**
INTRA**SPINAL**
about 10mL or less
33
# **ROUTE OF ADMINISTRATION**
INTRA**VENOUS**
about 250mL (infusion sets)
about 20mL or less (syringe)
34
* it is important for the **comfort of the patient**, especially for the **intraspinal injection**
ISOTONICITY
35
* controls **airborne microorganisms**
ULTRAVIOLET RADIATION
MERCURY VAPOR LAMPS
36
* personnel must be protected from **direct exposure** from UV by installing
DEFLECTORS
37
# **AMPULE-SEALING METHODS**
**Flame-seals** using **propane** and **tech grade oxygen** at ____ psi
10-20 psi
38
# **AMPULE-SEALING METHODS**
* ampules are sealed by **heating the neck** (below the tip) of the ampule, leaving enough of the tip for **grasping with forceps** or other **mechanical pulling device**
PULL SEALING METHOD
39
# **AMPULE-SEALING METHODS**
* a **slower** method but **seals much more sure**
PULL SEALING
40
# **AMPULE-SEALING METHODS**
these are sealed by **Pull sealing method**
funnel-topped ampules
41
# **AMPULE-SEALING METHODS**
* ampules are sealed by **melting enough glass at the TIP** of the ampule neck, to **form a bead** and **close the opening**
TIP-SEAL method
BEAD SEALING method
42
# **AMPULE-SEALING METHODS**
these are sealed using **Tip seal method**
standard ampules
43
an **improperly** or **insufficiently** sealed ampule is called
LEAKER
44
it is the **official sterility testing method** recommended by the FDA
MEMBRANE FILTRATION METHOD
45
it is an another official method of sterility testing wherein **turbidity is the measure of growth of microorganisms**
TEST TUBE INOCULATION METHOD
46
PYROGEN TEST:
* in **vivo** testing method show **physiologic response** to **fever** similar to the human body
QUALITATIVE FEVER RESPONSE IN RABBITS
47
PYROGEN TEST:
* used to **induce fever** in rabbits
Brewer's yeast
48
PYROGEN TEST:
* used as **negative control**
NSS
49
* an in **vitro**, **pass-fail test** for pyrogens based on; **gelling**, **color development**
* determined by the presence of **lysate** on the **HORSESHOE CRAB (*Limulus polyphemus)***
* harvesting of the **amoebocyte lysate** in the blood
LIMULUS AMOEBOCYTE LYSTAE (LAL) method
50
ALTERNATIVES TO **LAL** METHOD
Bacterial endotoxin test
Monocyte activation test
51
* test conducted to **prevent** the distribution and use of parenterals that **contain particulate matter**
* **intravenous injectables** require the most critical evaluation
CLARITY TEST
52
* ampules that have been sealed by **fusion** MUST BE subjected to this test, to determine whether or not a **passageway remains open outside**
LEAKER TEST
53
LEAKER TEST:
* releases **air bubbles** from the open capillary of the ampule
BUBBLE TEST
54
LEAKER TEST:
* acquires the **blue color** of the dye in its content
METHYLENE BLUE DYE TEST
55
* a test required for **most biologicals**, since it is entirely possible for a parenteral drug to pass the route sterility test, pyrogen test, and chemical test and still can **cause unfavorable reactions** upon injection
SAFETY / TOXCITY TEST
56
# **PACKAGING, LABELING, STORAGE**
parenterals intended for **intraSPINAL**, **intraCISTERNAL** or **EPIDURAL** administration are packaged ONLY in
SINGLE DOSE CONTAINERS
57
# **PACKAGING, LABELING, STORAGE**
**NO multiple-dose** containers shall contain a **fill volume** of ____
NMT 30mL
58
# **PACKAGING, LABELING, STORAGE**
preparations labeled for **dialysis**, **hemofiltration** or **irrigation** must bear the statement
NOT FOR INTRAVENOUS INJECTION
59
# **PACKAGING, LABELING, STORAGE**
**Biologicals** are stored under ____
refrigeration at 2-8C
60
* solutions intended to **bathe** or **wash wounds**, **surgical incisions** or **body tissues**
IRRIGATION FLUIDS
61
IRRIGATION FLUIDS:
* **vehicle**
sterile water for irrigation
62
IRRIGATION FLUIDS:
* washing **blood** and **surgical debris**
acetic acid for irrigation
63
IRRIGATION FLUIDS:
* as **topical wash** for **wounds & enemas**
sodium chloride for irrigation
64
**pyrogenic materials** STRONGLY ADHERE to ____
glass
65
# **ADDED SUBSTANCES**
* msut be added to preparations contained in **multiple dose containers**
* must be present at **adequate concentrations** at the **time of use** of the product, to prevent the **multiplication fo microorganisms**
* must be studied with respect to **compatibility** with other formualtion ingredients
ANTIMICROBIAL AGENTS
66
# **ADDED SUBSTANCES**
* compounds contributing to the **ISOTONICITY** of the product
* **reduce the pain** of injection in areas with sensitive nerve endings
TONICITY CONTRIBUTORS
67
# **ADDED SUBSTANCES**
* stabilize the solution agaisnt **chemical degradation** that might occur if the pH is changed appreciably.
* the **acid salts** are the most frequently employed buffers such as **citrates**, **acetates**, and **phosphates**
BUFFERS
68
# **ADDED SUBSTANCES**
ANTIOXIDANT:
* the **common choice** of formulators
Sodium bisulfite 0.1%
69
* used to **seal** the **openings** of **cartridges**, **vials**, and **bottles** by providing a material that is **soft** and **elastic** enough to permit the netry and withdrawal of a hypodemric needle
RUBBER CLOSURES
70
* for parenteral products, these are used to **crimp** the rubber closures **in place**
METAL CAPS
aluminum caps
71
* the best indication of the efficiency of an **aseptic filling process**
* done by **filling** and **sealing sterile fluids** in sterile containers under the **same conditions** used for the **aseptic fill** of the product
* the entire lot is **incubated** and examined for the appearance of growth of microorganisms
TOTAL STERILITY TESTS
72
it operates on the principle of the measurement of **light-scattered** from particles passed through the optical system
INSTRUMENTAL SCANNERS
73
* also termed as **POLISHING**
* requires the **removal** of **particulate matter** down to at least 3-5 microns in size
* employde for **heat-labile** parenteral solutions only
FILTRATION OF PARENTERAL SOLUTIONS
74
# **CLASSES OF FILTERS FOR STERILIZATION BY FILTRATION METHOD**
* **retains**microorganisms on its **surface** and is **not distorted** by pressure
* requires **no pre-treatment** and maybe sterilized by autoclaving or gas
* the **officially recognized filter media** used in the USP/FDA because it porvides the **best flow rate**
* disadvantage: **surface clogging**
* remedy: use a **porous pre-filter**
CELLULOSE ESTER MEMBRANE
75
# **FILLING & PACKAGING**
* in filling **sterile solids (antibiotics)** the RATE OF FLOW is **slow & irregular**, this can be **remedied** by using a filling machine equipped with an ____
AUGER or FILLING WHEEL
76
# **STERILIZATION**
THERMAL METHODS:
* applicable for substances **unaffected** by temperatures of 140-260C in the ovem, at the exposure time of **45 minutes**
* this method **kills spores** as well as **vegetative forms of microorganisms** by **OXIDATION WITH HEAT**
* ideal for sterilization of: **anhydrous oleaginous vehicles**, **glasswares**, **metalwares**
DRY HEAT METHOD
77
# **STERILIZATION**
THERMAL METHODS:
* **more effective** than dry heat method
* **destroys spores** and **vegetative bacterial forms** by **COAGULATION OF ITS CELL PROTEIN**
* makes use of an **autoclave**, setting at **121C** for **20mins** at **15 PSI**
* ideal for **rubber stoppers**, **glasswares**, **bottles/ampules/vials**, **uniforms**, and **cellulose membrane filters**
MOIST HEAT METHOD
78
# **STERILIZATION**
setting for **autoclave**
121C
20mins
15 PSI
79
# **STERILIZATION**
THERMAL METHODS:
* makes use of **moist heat method** at **100C** and normally performed at **2-3 exposures**, alternated with intervals at room or incubator temperature
FRACTIONAL METHOD:
TYNDALLIZATION
80
# **STERILIZATION**
THERMAL METHODS:
* makes use of the **dry heat method** at **60C**, alternated with intervals at room or incubator temperature for **2-3 days**
FRACTIONAL METHODS:
INSPISSATION
81
# **STERILIZATION**
THERMAL METHODS:
* effective for **vegetative forms of microorganisms** but **NOT for spores**
* addition of **bacteriostatic agents** may be used to improve such method
FRACTIONAL METHODS
82
# **STERILIZATION**
NON-THERMAL METHODS:
* aid in the **reduction of AIRBORNE contamination** produced by **mercury-vapor lamps**
* has **poor penettration** capability
ULTRAVIOLET IRRADIATION
83
# **STERILIZATION**
NON-THERMAL METHODS:
* makes use of **high energy** emitted from **radioactive isotopes**
* **gamma rays** are more reliable, becasue there is **no mechanical breakdown**
* disadvantage: **rare source** and **cannot be immediately shut-off**
IONIZATION RADIATION
84
# **STERILIZATION**
NON-THERMAL METHODS:
* applicable for sterilization of **heat-labile** parenteral solutions
* the heat labile solution is passed through **cellulose ester membrane** by vacuum filtration
STERILIZATION BY MEMBRANE FILTRATION
85
# **STERILIZATION**
* a mixture of **formaldehyde** and **sulfur disoxide gas** has a problem of leaving **residual deposits**, which is **difficult to remove**
* a mixture of **ethylene oxide** and **beta-propiolactone** is **limited** to sterilization of **dry powders** and **plastic containers**
CHEMICAL METHODS
86
# **STERILIZATION**
CHEMICAL METHODS:
* it is done by **autoclaving** the material at **55C** at **27 psi**
* **gas sterilizing agents** are introduced -- exposure is timed at **60 minutes/1 hour**
GAS STERILIZATION
87
# **STERILIZATION**
CHEMICAL METHODS:
* ideal for sterilization of **work surfaces** and **rooms** with the use of **chemical disinfectants** for environmental control
* **Lysol**, **Chlorox / Zonrox** may be used
* **Phenolic** and **Quaternary ammonium compounds** are also used
SURFACE DISINFECTION
88
RINGER'S SOLUTION APIs
Sodium chloride
Potassium chloride
Calcium chloride
89
RINGER'S SOLUTION:
* **diluent / vehicle**
Sodium Chloride
90
RINGER'S SOLUTION:
* **stabilizing agent**
Calcium chloride
91
RINGER'S SOLUTION:
* **electrolyte replenisher**
Potassium chloride
Manuf LAB
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