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Instrument used for the Light Transmission Test

UV-Vis Spectrophotometer

Wavelength range for Light Transmission Test limits

290-450 nm

Containers that require a Light Transmission Test

Light-resistant containers only

Purpose of the Chemical Resistance Test

Determines the resistance of new glass containers to water attack

Basis for measuring glass water attack

Amount of alkali released from the glass

Trituration technique used in glass testing

Direct acidimetry

Direct acidimetry result Red

acidic

Yellow result

basic

Indicator used for glass chemical resistance titration

Methyl orange

Glass types tested using the Powdered Glass method

Types I, III, and NP

Preparation step for the Powdered Glass method

Glass is pulverized, water is added, then autoclaved

Glass type tested using the Water Attack at 121°C method

Type II

Condition of Type II glass during the Water Attack test

Analyzed as a whole (not pulverized) Placed in water and autoclaved

Specific acid used in glass testing autoclaving process

0.1 N H2SO4

Purpose of the Permeation test

Determines the moisture permeability of a container

Sample size for the Permeation test

12 bottles

Desiccant used in the 10 test containers for Permeation

Anhydrous CaCl2

Contents of the 2 control containers in the Permeation test

Glass beads

Storage conditions for Permeation test

14 days at 20 ± 2°C and 75 ± 3% RH

Substance used to maintain relative humidity in the Permeation desiccator

Saturated NaCl solution

Unit for computing the rate of moisture permeability

mg/day/Liter

Titrimetry method used for Heavy Metals testing

Complexometry

Heavy metals Instrument method of analysis

AAS (HCL + Metal)

Purpose of Biological Reactivity Tests, In Vitro

Determine the biological reactivity of mammalian cell cultures to plastics and polymers

The three In Vitro Biological Reactivity Tests

1. Agar Diffusion Test, 2. Direct Contact Test, 3. Elution Test

Role of the Agar layer in the Agar Diffusion Test

Acts as a cushion to protect cells from mechanical damage while allowing the diffusion of
leachable chemicals from the polymeric substances

Feature of the Direct Contact Test regarding the cell-material interface

No agar layer; material is in direct contact with cells

Medium used in the Direct Contact Test to nourish cells

Serum-supplemented medium

Purpose of the Elution Test

Evaluation of extracts of polymeric materials

Specific evaluation possible with the Elution Test

high-density materials and for Dose-response evaluations

Primary goal of Biological Reactivity Tests, In Vivo

Determine biological response of animals to elastomerics and plastics

NONVOLATILE RESIDUE

Gravimetric method

THERMAL ANALYSIS

DSC thermogram

RESIDUE-ON-IGNITION (ROI)

Gravimetric method

BUFFERING CAPACITY

Potentiometric titration

____ is under the agar layer, which acts as a cushion to protect it from any mechanical damage from the biomaterial. The components of the biomaterial will leech so, it can still reach

mamalian cell culture

allows for simultaneous extraction and testing of leachable chemicals from specimen with serum-supplemented medium

DIRECT CONTACT TEST

not appropriate for very low- or high-density materials that
could cause mechanical damage to the cells

DIRECT CONTACT TEST

allows extraction of the specimen at physiological or non-
physiological temperatures for varying time intervals

ELUTION TEST

We extract the component of the material. It is not the material itself.

ELUTION TEST

Primary goal of In Vivo Biological Reactivity Tests

Determine biological response of animals to elastomerics, plastics, and other polymeric materials

Method of contact in In Vivo Biological Reactivity Tests

Direct or indirect patient contact, or injection of specific extracts

Does not use mammalian cell culture. Rather, it will be injected on animals

In Vivo Biological Reactivity Tests

Systemic Injection Test target animal

Mice

Purpose of Systemic Injection Test

Evaluate systemic responses to extracts or materials under test following injection

Intracutaneous Test target animal

Rabbits

Purpose of Intracutaneous Test

Evaluate local responses to extracts or materials under test following intracutaneous injection

Purpose of Implantation Test

Evaluation of plastic and polymeric materials in direct contact with living tissue

Common materials for closures/caps

Tin plate, aluminum, thermoplastics, rubber

Two different kinds of closures

1) Threaded screw caps, 2) Push-on or Plug-type closures

Two types of Threaded screw caps

Preformed (e.g., lug cap) or formed during application (e.g., roll-on and pilferproof)

Difference between Lug-cap and full-on threaded cap

Lug-cap requires a quarter turn; full-on threaded requires a 100% turn

Purpose of the Torque Test

Measures the tightness of the cap

Definition of Torque

Circular force required to loosen the cap

Definition of Application Torque

Force used to tighten the cap

Sample size for the Torque Test

10 bottles

Unit of force for the Torque Test

Inch-pound

Purpose of Water Vapor Transmission Test for closures

Measures the efficiency of the closure system

Sample size for Water Vapor Transmission Test

5 bottles

Frequency of weight loss determination in Water Vapor Transmission Test

Every month

Limit for Water Vapor Transmission Test

Not More Than (NMT) 3% loss in one year

Three categories of Quality Control tests on Raw Materials

1. Physical and Organoleptic, 2. Identification, 3. Limit of Impurities

Examples of Physical and Organoleptic examination

Color, odor, dimensions

Examples of Physical identification tests

Optical rotation, specific gravity, refractive index, molecular weight

Three types of impurities checked in Limit tests

Gross, Chemical, and Biological impurities

Purpose of Microbial Enumeration Test

Estimate the number of viable aerobic microorganisms

Test organisms for Microbial Enumeration Test

A. brasiliensis, B. subtilis, C. albicans, E. coli, S. aureus, Salmonella typhimurium

Media used for bacteria in Microbial Enumeration

Soybean-Casein Digest Broth or Agar

Media for Bacteria: B. subtilis, E. coli, S. aureus, Salmonella typhimurium

Soybean-Casein Digest Broth or Agar

Media used for fungi in Microbial Enumeration

Sabouraud Dextrose Agar

Media used for A. brasiliensis C. albicans

Sabouraud Dextrose Agar

Purpose of Antimicrobial Effectiveness Testing

Determine efficacy of antimicrobial preservatives added in the formulation

Test organisms for Antimicrobial Effectiveness Testing

C. albicans, A. niger, P. aeruginosa, E. coli, S. aureus CAPES

Purpose of Antibiotics Microbial Assay

Determines the potency of antibiotics

Two methods for Antibiotics Microbial Assay

(a) Cylinder plate or plate, (b) Turbidimetric or tube assay

Indicator of potency in the Cylinder plate method

The clear zone (Zone of Inhibition)

Alternative name for Turbidimetric assay

Tube assay

Basic document used as the source for the master formula and batch production records

Manufacturing Monograph

The three components included in a Manufacturing Monograph

1) Master formula, 2) Master production document, 3) Master packaging document

Definition of Batch Records

Collective term for all records generated during the production of a quality-controlled batch

BATCH RECORDS includes

1) Batch production record
2) Batch packaging record
3) Batch control records

Examples of Batch Control Records

RTR, quarantine report, sampling frequency, sample taken, resample request, testing frequency, disposition, certificate of disposal, stickers

Purpose of an SOP in manufacturing

Explains reason behind a procedure and proper sequence of steps for maximum equipment performance

Two components included in a Quality Control Monograph

1) Testing Methods, 2) Specifications

Retention period for documents and samples (ANSI standard)

1 year after the expiration date

Retention period for documents/samples based on distribution

2 years after distribution

Retention period for documents/samples based on manufacture date

5 years from date of manufacture

Criteria for choosing between different retention periods

Whichever is shortest

Definition of Line Clearance in packaging control

Removal of anything in the packaging line prior to starting another packaging run

Primary goal of Line Clearance

To avoid cross-contamination from other batches

Advantage of a Distribution Card over a stockard during a recall

It contains the name of the retailer

Entity that provides Batch Certification

Regulatory agency

Rule for the order of product distribution

Oldest approved lot is distributed first (FEFO/FIFO principle)

Procedure for a product that does not conform to specifications

Rejected or Reprocessed

Requirements for reprocessing a batch

Must be reviewed/approved by QC, potential risks eliminated, and process documented

Additional requirement for a reprocessed final product

Follow-up stability study

Three sources that can undergo reprocessing

a) Recovered materials, b) Product residues, c) Returned goods

Key focus of Environmental Control regarding water

Regular monitoring of the process water

Other aspects of Environmental Control

Periodic monitoring of production area and control of airborne contaminants

Purpose of retesting approved materials after storage

To establish identity, strength, purity, and quality