Moisture Permeability Test -a quality control test Procedure 1.

12 bottles (10 of which are test bottles; 2 of which are control bottles) 2. Place CaCl (dessicant) on the control bottles and on the test bottles, glass heads 3. Store for 14 days @ 20 2C and 75 3% RH Rate of Moisture Permeability
mg/day/L

-has no threads -can be closed only through a press on closure 7. Handle -has a handle on the finish 8. Pour-Out -has a funnel-like mouth (threaded; threaded means continuous) 9. Roll-On -has a roller Five Basic Designs of Bottle Closures 1. Screw On Closure -has a thread that will engage on the corresponding thread on the bottle a. Threaded Screw Cap -has a continuous thread -requires a full turn b. Lug Cap -has broken/interrupted threads -requires a quarter turn -provides a hermetic seal 2. Crimp On Closure -also called as crown -tansan in tagalog -usually for beverages -not applicable for threads -oldest type of closure 3. Roll On Closure -makes use of aluminum material -can be sealed securely -opened easily -reseal effectively a. Re-sealable Roll On -once opened, it can be resealed b. Non Re sealable Roll On -has tear off tabs -has no threads -found on vials c. Tamper Proof/Pilfer Proof -greater skirt length 4. Press On/Snap On Closure (partner : pry off) 5. Friction Type Closure (partner : biological)

RMP

= 1000 (Tf-Ti) (Cf -Ci) 14v

V= Ti= Tf= Ci= Cf=

volume capacity of the bottle in mL initial weight of test containers final weight of test containers initial weight of control containers final weight of control containers

Limits Tight containers n.m.t 1 out of 10 exceeds 100mg/day/L and none exceeds 200mg/day/L Well closed containers n.m.t 1 out of 2000 exceeds 100mg/day/L and none exceeds 3000mg/day/L High density containers n.m.t 1 out of 10 exceeds 100mg/day/L and none exceeds 25mg/day/L Low density polyethylene n.m.t 1 out of 20 exceeds 100mg/day/L and none exceeds 30mg/day/L

Bottle Finish -design from the mouth to the neck Several Types of Finishes 1. Shallow Continuous Thread -one revolution 2. Tall Continuous Thread -two or more revolutions 3. Sprinkle Top -has a narrow mouth 4. Lug Amerseal -has broken threads -found in hermetic containers 5. Biologicals -has no threads -can be closed only through friction -usually corks, rubber/glass stoppers 6. Pry-Off

Materials Used as Bottle Closures 1. Metals 2. Plastics (urea,PE,PP,PS,PVC) Capliners 1. Homogenous -a disc of rubber plastics

2.

Heterogenous -layers of different materials -facing and backing -facing (PE, vinyl, Al) -backing (serves as a cushion and provide sealing properties eg. pulp paper)

-for Type 2 Limits Type 1 Type 3 Type4 Type 2

Types of Glass Containers 1. Highly Resistant Borosilicate Glass (Type 1) -composed of boric oxide and silicon dioxide -low thermal coefficient of expansion -chemically resistant -least reactive -low leachability -suitable for all products 2. Treated Soda Lime (Type 2) -Na oxide and Ca oxide -interior surface is treated with sulfur dioxide (alkalizer) -chemically less resistant to leaching than Type 1 -more resistant than Type 3 -higher thermal coefficient of expansion -used for buffered solutions -solutions with pH below 7 -solutions not reactive to glass 3. Soda Lime Glass (Type 3) -not treated with sulfur dioxide -has higher concentration of migratory oxides than Type 2 -anhydrous liquids -dry substances -not for products to be autoclaved 4. General Purpose Soda Lime Glass (NP) (Type 4) -non parenteral -not for products that contain parenterals -only for capsules, tablets and topical products Two Quality Control Tests that Determine Glass Types Chemical Resistance Test -resistance to water attack of new glass container - oxide +water=hydrogen peroxide -standard acid: 0.02 N hydrosulfuric acid Methods a) Powdered Glass Test -pulverize the glass -subject it to water -for Types 1,3 and 4 -Type 2 is not used because it is treated b) Water Attack Test -performed on the whole container

1.0mL of the standard acid 8.5mL of the standard acid 15mL of the standard acid 100 0.7 mL >100 0.2

Light Transmission Test -measures the maximum % light transmission at wavelength 290-450nm Limits Type IV n.m.t 10% Types I III and Plastic Classes I IV Nominal Size (mL) 1 2 5 10 20 50 Flame Sealed 50 45 40 35 30 15 Closure Sealed 25 20 15 13 12 10

Description of Bottles 1. According to Shape a. Boston Round b. Blake 2. According to Color a. Flint b. Amber 3. Size 4. Method of Manufacture a. Glass blowing b. Molding

244-OD (molder #)

39 Cavity #

M S

12 Year of manufacture

60 Volume of capacity

Bottle Defects -an undesirable characteristic Types of Defects According to Gravity

Critical Defects -hazardous to consumers and may render the product useless 1. Bird Swing and Spike

b. Sampling Inspection 5. How to report data? 6. Material Handling 7. Administrative Procedures Sampling Inspection -representative units of the batch are being inspected

2. 3. 4. 5. 6. 7. 8. 9. 10.

Overpress -rim extending from the inside edge of the finish and sometimes sharp Filament -hair -like string of glass inside the bottle Split -open crack starting @ the top of the finish and extending downwards Cheek -small shallow surface crack (gasgas) -group of check is called grizzle Freak -odd shapes and conditions that render the container completely unusable Poor Distribution -uneven thickness of the glass Soft Blisters -are thin blisters that can be easily broken Crack -partial fractures found at the heel area (bottom) and shoulders Pin hole -any opening causing leakage

Risk of Errors 1. Producers Risk -Risk of rejecting a good batch 2. Consumers Risk -Risk of accepting a bad batch Sampling -a process of removing an appropriate member of items from a population to make inferences of the entire population Kinds of Sample 1. Gross Sample Number of containers where laboratory samples are withdrawn 2. Laboratory Sample The sample for QC Tests 3. Test Samples (Where Applicable) -the sample that has to undergo some modification prior to the actual tests Sampling Plan -a definite working rule regarding the size and frequency of sample and the basis for acceptance or rejection N = Batch Size N = Sample Size Ac/c = Acceptance Number Acceptance Quality Control (AQL) -maximum % defectives AQL 10, serious defects (eg. critical, major) -maximum % defects AQL >, trivial defects (eg. minor) Sampling Plans 1. Square Root System n=N+1 2. Government Sampling Plan used to compute for lab sx Special Inspection Levels -relatively small sample size is necessary and large sampling risk can be tolerated General Inspection Levels Level I -used when less discrimination is needed when supplier has good reputation Level II -used when the reputation of the supplier is not specified Level III -used for greater discrimintation -for new suppliers *AQL = 22 So, 22 is the maximum # of defects per 100 units 25 bundles x 1000 labels N= 25 n= 6 bundles ^ Use the square root system Population size in lab sx = 25000 labels/ unit Sample size = 315 labels Number of labels/ bundle = 315/6 = x Acceptance Number = 14 ; Rejection Number = 15 Square Root System -in computing the gross sample, it is not always a whole number -when thers a decimal point, round up (+ 1) 55 bundles x 100 labels Serious defect lower AQL

Major Defects -affects the usability of the container 1. Chip -piece or pieces of broken glass at the top edge 2. Stone -small inclusion of a non glass material 3. Rocker Bottom -uneven portion @ the bottom 4. Mismatch -half of the finish maybe shifted to the side or upward of the other half 5. Fin -a seam @ the top surface or down the side @ the fusion line 6. Out Of Round Finish -pinched, flattened or oval finish Minor Defects -not critical -only affects the appearance and acceptability of the consumers 1. Sunken/ Dropped Shoulders -produced when bottles sag after blowing 2. Tear -similar to check but opened up 3. Washboard -horizontal lines on the body of the bottle 4. Brushmarks/ Marks -vertical lines on the body of the bottle 5. Dirt -scaly or granular non-glass materials 6. Heel Tap -heavy glass on one side of the bottom 7. Hard Blisters - deeply embedded blisters 8. Stack -rough spot produced when pulling bottoms that stick together 9. Long Neck -stretched out neck resulting from bottles being too hot When picked up by the machine 10. Seeds -small bubbles in the glass -air bubbles, generally smaller than blisters -pinheads size 11. Neck Ring Seam -bulge at the fusion line at the neck ring - like a fin but the seam is thin at the neck ring Inspection -performed by alert individuals who have understood the written instructions in the SOP 1. When to inspect? 2. What to inspect? 3. Inspection Standards 4. Inspection Methods a. 100% Inspection