Quality Control of Packaging Materials

Views:
 
Category: Education
     
 

Presentation Description

Several QC tests are performed for both primary and secondary packaging materials. I have concised the set of QC tests in this presentation.

Comments

Presentation Transcript

Slide1:

A Seminar on QUALITY CONTROL OF PACKAGING MATERIALS Presented by Dr. S. VIJAYARAJ Department of Pharmaceutical Analysis Sree Vidyanikethan College of Pharmacy, Tirupati

INTRODUCTION:

INTRODUCTION In pharmaceutical industry it is vital that package selected preserve the integrity of product. The selection of package begins with determination of products physical & chemical characteristics. Quality control of a packaging component starts at design stage. All the aspects of a pack development may give rise to quality problems. It must be identified & minimized by performing quality control tests.

QUALITY CONTROL TESTING & STANDARDS:

QUALITY CONTROL TESTING & STANDARDS The packaging materials are classified into two classes, Primary:- ampoules, vials, plastic bottles, polymer-coated foils. Secondary:- cartons, labels, leaflets

PRIMARY COMPONENTS:

PRIMARY COMPONENTS Setting the standards: Several distinct areas are taken in to concern for setting the standards, 1.Appearance 2.Dimension 3.Compatability & customer usability 4.Chemical testing

Slide5:

APPEARANCE 1.Critical 2. Major 3. Minor A suitable Acceptable Quality Limit (AQL) is set for the major and minor categories. An AQL must not be set for critical defects since these are unacceptable at any level. A Tighter AQL will be set for major defects (eg: 0.65AQL) than for minor defects(eg:2.5 AQL)

Slide6:

The critical dimensions for each compounds are as follows Vial: Flange depth, flange diameters, bore diameters, vial heights, body diameters, wall thickness, base thickness, & verticality. Rubber Plug: Flange depth, flange diameters, & plug diameters. Aluminum Overseal: Internal skirt depth, external diameter, and aluminum thickness. DIMENSIONS The dimensions can be separated in to two types Critical Non critical

CRITICAL DIMENSIONS:

CRITICAL DIMENSIONS

Slide8:

CRITICAL DIMENSION DEFECTS EFFECTS Flange depth Variation in flange depth Improper tucking of Aluminum skirt. Flange diameters Too large a diameter Aluminium overseal could not fit over the flange Too small diameter Overseal skirt would not tuck under the vial flange Bore diameter Too large a bore Rubber plug would have loose fit. Too small a bore The plug could not be inserted. Vial height The height of vial varies Sealing mechanism will not operate satisfactory. A high vial May even be crushed by the filing-machine sealing mechanism. Body diameters Vial with too large diameter Small diameter Cannot travel down the conveyor track. May not align to sealing mechanism correctly.

Slide9:

Wall thickness & base thickness Too thin wall May crack or break during washing, sterilizing or frilling. Too thick wall Vials may be too hot when they exit tunnel resulting in rapid cooling, with the possibility of cracking. Concentricity Amount of flange movement when vial is rotated about center Results in misalignment of flange with sealing mechanism. Preventing plug insertion & oversealing. Verticality Max angle of lean measured from base when vial is placed in horizontal surface & rotated about its center. Misalignment of flange on sealing mechanism. Prevents plug insertion & oversealing

Vial Sealing Machine:

Vial Sealing Machine

Vial Sealing Machine:

Vial Sealing Machine

MEASURING COMPOUNDS:

MEASURING COMPOUNDS Various measuring equipments used are Optical Projector Calipers Micrometer

OPTICAL PROJECTOR:

OPTICAL PROJECTOR To measure flange depth or neck height an optical projector is the best choice of equipment.

CALIPERS FITTED WITH SPECIAL JAWS:

CALIPERS FITTED WITH SPECIAL JAWS The jaws must be exactly vertical to the wall surface to obtain an accurate measurement.

MEASUREMENT OF SPECIFIC POINT:

MEASUREMENT OF SPECIFIC POINT

MEASUREMENTS AT CENTER OF BASE :

MEASUREMENTS AT CENTER OF BASE Done with dial caliper

MICROMETER:

MICROMETER A different set of jaws will be required for each plug size to be measured. The ideal size of micrometers for this purpose is 25-50mm.

CAPABILITY AND CUSTOMER USABILITY:

CAPABILITY AND CUSTOMER USABILITY Eye dropper pack Nozzle must have good interference fit in to the bottle & allow one drop at a time though nozzle hole when inverted. No leak should be noted. Cap should be capable of begin removed by customers easily

CHEMICAL TESTING:

CHEMICAL TESTING Glass container :

IMPORTANT CHEMICAL TESTS :

IMPORTANT CHEMICAL TESTS Hydrolytic resistance test. Water attack test. Powdered glass test Light transmission test. Arsenic test

HYDROLYTIC RESISTANCE TEST:

HYDROLYTIC RESISTANCE TEST Determine average overflow volume Auto clave at 121  C for 60 minutes Combine the liquid from container being examined To 50ml liquid add 0.15 ml methyl red solution and titrate to 0.01 M Hcl Repeat the same with freshly prepared distilled water. The difference between the two represents 0.01M Hcl required by test solutions.

Slide22:

Capacity of container corresponding to 90% of average overflow volume (ml) Volume of 0.01M Type I/ II Hcl/100ml Type III NMT 1 2.0 20.0 More than 1 but NMT 2 1.8 17.6 More than 2 but NMT 5 1.3 13.2 More than 5 but NMT 10 1.0 10.2 More than 10 but NMT 20 0.8 8.1 More than 20 but NMT 50 0.6 6.1 More than 50 but NMT 100 0.5 4.8 More than 100 but NMT 200 0.4 3.8 More than 200 but NMT 500 0.3 2.9 More than 500 0.2 2.2

DISTINCTION BETWEEN TYPE I AND TYPE II:

DISTINCTION BETWEEN TYPE I AND TYPE II Rinse the container twice in distilled water Fill completely in 4% v/v solution of hydrofluoric acid, allow to stand for ten minutes. Empty and rinse the container five times in water. Carry out procedure same as hydrolytic resistance. Compare results in limiting values given in table -1. For type I glass values obtained in HF treated containers are closely similar to type I /type II. For type II glass values obtained in HF treated containers greatly exceed those given in table for Type I/ Type II similarly to those given in Type III.

Slide24:

2. Powdered glass test: 3. Water attack test: Mainly done for treated soda lime glass. 4.Light transmission test: Measure the transmission in reference to air at spectral region of 290nm to 450nm. The Observed light transmission for coloured glass containers for preparation not for parental use does not exceed 10% at any wavelength. Observed light transmission for coloured glass containers for parental preparation does not exceed the limit in the table

Slide25:

Result is not greater than value stated in table1. No. of containers used Max percentage of LT at any wavelength between 290nm and 450nm Flame sealed containers Containers in closures Up to 1 50 25 Above 1 & up to 2 45 20 Above 2 & up to 5 40 15 Above 5 & up to 10 35 13 Above 10 & up to 20 30 12 Above 20 15 10

TEST FOR ARSENIC:

TEST FOR ARSENIC LIMIT : the absorbance of test solution does not exceed the absorbance obtained by repeating the same with 0.1ml arsenic standard solution (10ppm) in place of test solution (0.1ppm).

OTHER IMPORTANT TEST FOR GLASS CONTAINER:

OTHER IMPORTANT TEST FOR GLASS CONTAINER Thermal shock test: The samples are placed in an upright position in a tray which is immersed into hot water for given time, then transferred to cold water bath. Samples are examined before & after the tests for outside surface cracks or breakage. Internal bursting pressure test: The test bottle is filled with water & then placed inside the test chamber. A sealing head is applied & the internal pressure automatically raised by series of increments. Each increment is held for a set time. The bottle can either be checked to a pre selected pressure level or the test continued until the container finally bursts. Annealing test: The sample is examined by polarized light in either a polariscope or strain viewer. The strain pattern is compared against standard discs or limit samples. Vertical load test: The bottle is placed between a fixed platform & a hydraulic ramp platform which is gradually raised so that a vertical load is applied. The load is registered on pressure gauge. Autoclaving (121  C for 60 min) Ability of a filled or empty container to withstand autoclaving may be checked.

AMPOULES:

AMPOULES Testing of Ampoules sealing: Appearance Head space oxygen Sealed Ampoules length Quality of seal:

STRESS PATTERNS IN SEALED AMPULES:

STRESS PATTERNS IN SEALED AMPULES

PLASTIC CONTAINERS:

PLASTIC CONTAINERS Plastic containers can be mainly categorized as 1.Thermosetting plastics(cannot be remelted) 2.Thermoplastics (can be reprocessed) WHO guidelines on selection of plastics on pharmaceutical preparations. INFUSION AND INJECTIONS Physicochemical on aqueous extracts Non volatile residue, heavy metals, buffering capacity, reducing substances Biological invivo Acute systemic toxicity in mice Intra cutaneous test (rabbits), cardiovascular (cat) toxicity infusions Biological invitro Haemolytic effect of aqueous extracts

Slide31:

Physicochemical on aqueous extracts Non volatile residue, buffering capacity, reducing substances Biological test on aqueous extracts Eye irritation in rabbits on repeated instillation (Draize test) AQUEOUS OPHTHALMIC PREPARATION

PHYSICOCHEMICAL TEST ON AQUEOUS ON EXTRACT:

PHYSICOCHEMICAL TEST ON AQUEOUS ON EXTRACT Appearance Light absorption pH Non-volatile matter Residue on ignition Heavy metals Buffering Capacity Oxidisable substances

BIOLOGICAL TESTS:

BIOLOGICAL TESTS Systemic injection test: Test animal – Albino Mice Inject each of 5 mice in test group with sample or blank observe the animals immediately, again after 4hr & then at 24, 48, 72hrs. If none of animals shows significant greater biological reactivity than the blank the sample meets the requirements. If abnormal behavior such as Convulsion or Prostration occurs or if body weight loss is greater than 2g, the sample does not meet the requirements. Intra cutaneous test: Test animal- Rabbit Examine the sites of for any tissue reaction like erythema, oedema, neuosis at 24, 48, 72 hours after injection. Limit- difference between the scores of sample and blank should be lesser than 1.0. Eye irritation test on rabbits: Test animal - albino rabbits Limit- Sample extract shows no significant irritant response during the observation period with blank extract.

RUBBER CLOSURES:

RUBBER CLOSURES Rubber closures are used to seal the cartridges, vials and bottles, providing a material soft and elastic enough to permit entry & withdrawal of a hypodermic needle without loss of integrity of sealed container. QUALITY CONTROL TESTS : i) Fragmentation test : This test is applicable to closure intended to be pierced by a hypodermic needle & the closures used for aqueous preparation.   ii) Self-sealability test: This test is applicable to closures intended to be used in multidose container.

QC TEST FOR COLLAPSIBLE TUBES:

QC TEST FOR COLLAPSIBLE TUBES 1.Leakage Test 2. Lacquer Curing Test Power of Adhesion Flexibility Test 3.Lacquer compatibility test Product Compatibility Lacquer Compatibility

QUALITY CONTROL FOR METALLIC TINS:

QUALITY CONTROL FOR METALLIC TINS Protocols of test: Dimensions: Limit: Specimen metallic tins with tolerance 170mm  10mm. 3. Diameter: Inner diameter - Limit: It should not be less than 98mm. Outer diameter – Limit: NMT 105mm

QUALITY CONTROL TEST FOR STRIP & BLISTER PACKAGING:

QUALITY CONTROL TEST FOR STRIP & BLISTER PACKAGING The strips & blisters were placed inside the desicator & vacuum was applied. After sometime vacuum was released & strips, blisters were taken out. The water present over the outer surface of the packages was wiped off with tissue paper. The contents of strips & blister packages were removed & the presence of moisture was checked. If there is no leakage, the contents will not be wetted. This indicates the perfect sealing of packages.

SECONDARY COMPONENTS:

SECONDARY COMPONENTS Quality Control for Paper & Board based materials: The Following are the FDA approved case designs for packaging materials:

Testing of Paper & Board:

Testing of Paper & Board The test pieces for paper & board are conditioned for the tests to be carried out in standard conditions. Those conditions are Temperature - 23  C  1  C Relative humidity – 50%  2%

Slide40:

Name of the Test Description Moisture content All the substances will be measured at temperature specified for test Folding Endurance Fold the test piece back & forth until rupture occurs Density of paper & board For rigid cellular materials Method for determining air permeability Expressed in  m pa­­­­­­ -1 s -1 . It is important for using lightweight uncoated paper on machine having vacuum pick up system Grammage or substance (g/m 2 ) The weight of material per unit area of sample Paper Caliper Single sheet thickness between one surface and other Tensile strength The maximum tensile force per unit width that a paper or board will withstand before breaking Tear strength The mean force required to continue the tearing of an initial cut in a single sheet of paper Burst strength The maximum uniformly distributed pressure, applied at right angles to surface that a test piece of paper & board will stand under conditions of test. Hydraulic pressure is applied to diaphragm, bulging it until test piece bursts. Puncture resistance Energy required to make initial puncture Stiffness of thick paper & boards Degree of resistance offered by paper/board when it is bent Creasibility of boards Method to determine creasing quality of board within the range of 300-1000  m Cobb test(g/m 2 ) Test for water absorbency

Slide41:

Rub resistance This is resistance of printed test piece to withstand rubbing against another similar test piece Pick test/IGT test A specified amount of a special oil is added to the printing system & printed on to the test piece. The surface is then examined for signs of pick. pH, chloride or sulphate The acidity or alkality (pH) can help the life of the paper board Roughness/smoothness This is very important for ‘printablity’ of the paper. Brightness This is the reflectance factor measured at the effective wavelength of 457 nm Opacity This is ratio expressed as percentage of luminous reflectance factor of a single sheet of paper with a black backing to intrinsic luminous reflectance factor. Dennison wax test This is a older test and was replaced by the IGT test Wet burst strength It is used to determine wet bursting strength of any paper or board following immersion in water Wet tensile strength It is to determine wet tensile strength on immersion in water Ash in paper & board This is a method of determining the ash content in paper & board Detection & estimation of nitrogenous agents in paper It applies only to substances that have a strong affinity for acid dyes Ink absorbency The determination of ink absorbency of paper & board by K & N ink.

TEST FOR CARTONS:

TEST FOR CARTONS Compression: This method is used to assess the strength of erected package Carton opening force: The method is used to hold the flat carton as delivered, by its creases between thumb & first finger press. Coefficient of friction: Both static & kinetic coefficients of friction are determined by sliding the specimen over itself under specific test conditions. Crease stiffness: This involves testing a carton board piece & folding it through 90  . It will then try to recover its former position when bending force is removed. Joint shear strength: This is a method of testing the glued lap seam on the side of a carton for strength of the adhesive using a tensile testing machine.

CONCLUSION:

CONCLUSION Package for a specific drug will preserve the drugs efficacy as well as its purity, identity, strength and quality for its entire shelf life. It is mandatory for the manufacturers to prove the safety of packaging of material by performing the quality control tests as per the specification.

REFERENCE:

REFERENCE Quality Control of Packaging Materials in the pharmaceutical Industry-Kenneth, Harburn. Pharmaceutical Packaging Technology by D.A. Dean, L.R. Evans, I.H. Hall. The Theory and Practice of Industrial Pharmacy by Leon Lachman A. Liberman, Joseph L.Kanig III rd edition Indian Pharamacopoeia 1996 volume II page A- 127, 131,132 British pharmacopoeia volume IV, page A- 355 European pharmacopoeia volume I, page- 301 United states pharmacopoeia 2004, page-2288 www.googleimagesearch.com

authorStream Live Help