sieve & screen used in pharmaceutical manufacturing

SIEVES & SCREENS

Chandrakant Patil

[email protected]

Sieve & Screen Used In Pharmaceutical Manufacturing

SIZE SEPERATION & SIZE REDUCTION

Size separation is unit operation in the manufacturing of pharmaceutical dosage forms.

Particle size of raw materials directly affects on quality & performance characteristics of finished product.

The control on particles size and size distribution is required during manufacturing processes.

SIZE SEPERATION & SIZE REDUCTION

Various types of equipments are used during manufacturing of oral solid dosage forms for size separation & Size reduction.

For Example: Vibrosifters, Multimill, Communiting mill, Turbosifter cum Multimill & Oscillating granulator.

In the above mentioned equipments qualified /certified sieves & screens of appropriate mesh sizes shall be used to obtain desire particle size range.

Different types of sieves & screens are required w.r.t.type of equipment used during manufacturing process.

VIBROSIFTER SIEVES

MULTIMILL SCREEN

COMMUNITING MILL SCREEN

TURBOSIFTER CUM MULTIMILL SCREEN

OSCILLATING GRANULATOR SCREEN

COMILL SCREEN

FBD, FBE & FBP SIEVES

DETACHABLE POT SIEVES FOR LIQUID FILTRATION

HANDLING OF SIEVE & SCREEN IN PRODUCTION AREA

Standard Operating Procedure (SOP) for handling of sieve & screen in production area shall include:

Procedure for procurement of new sieve & screen.

Specification for sieve & screen.

In house coding procedure.

Inspection of new and used sieve & screen.

Inventory record of sieve & screen.

Cleaning & storage procedure.

Procedure for destruction of damaged/rejected sieve & screen.

PROCUREMENT OF SIEVE & SCREEN

Purchase requisition is raised in SAP for requirement of new sieve & screen. Mention all details for new sieve & screen while raising Purchase requisition.

Type of sieve & screen to be used depends on :

Type of equipment to be used during sifting & milling.

Desired particle size.

As per manufacturing process specified in Batch Manufacturing Record (BMR).

SIEVE SPECIFICATION

Sr.No. Specifications Requirement

1 Diameter For Example:750 mm

2 Mesh size For Example: 40#

3 MOC of wire mesh SS 316 quality

4 Silicone moulded The edge of the wire mesh shall be moulded with food grade quality, transparent & non-toxic silicone polymer .

5 Quantity As per requirement.

6 In- house coding details In- house coding details shall be inserted.

For Example:SISF/40#/001.7 Certificates MOC & Calibration certificates.

SIEVE SPECIFICATION : SPECIFICATION FOR WIRE MESH

Sr.No. Specifications for wire mesh

1 Crevice free GMP design. 2 AISI SS 316 quality.3 Free from toxic Lead & Tin metals.4 Calibrated & Certified as per International Standards.5 Super Taut with High Tensile strength.

The wire cloth stretched to induce tautness & results in a high tensile load bearing mesh.

The super taut sieve gives a better throughput, longer life & maintains uniform aperture size.

6 The sieve shall be easy to mount, use, wash & maintain.

7 Authentic certificates shall be provided with full traceability.

SIEVE SPECIFICATION : SPECIFICATION FOR SILICONE

Sr.No. Specifications for Silicone rubber

1 Transparent Silicone Enveloped design.

2 The edge of the wire mesh shall be molded in a Bio safe Toxicology tested polymer.

3 The silicone which used is of food grade quality, transparent in appearance & non-toxic.

4 Coding can be inserted as per user specifications.5 Authentic certificates shall be provided with full traceability.

SCREEN SPECIFICATION

Sr.No. Specifications Requirement

1 Screen size For example:1.0 mm

2 MOC SS 316 quality.

3 Quantity As per requirement.

4 In- house coding details In- house coding shall be engraved as SCMM/1.0/001.

5 Certificates MOC & Calibration certificates.



1 Crevice free GMP design. Screen shall be fabricated in a joint less design.

2 AISI SS 316 quality.

3 Free from toxic Lead & Tin metals.

4 Perforations shall be done in round profiles.

5 Proper reinforcement shall be given to the perforated sieve to withstand the impact generated by the hammer action of the blades.

6 The perforations shall be specially designed to reduce the chance of powder accumulation. The joints are argon welded to give a longer screen life.

7 Oscillating Granulator sieves are strong enough to bear the load of the raping blades yet are flexible enough to fit properly in the machine.



1 The perforated area shall be designed to give the maximum output & maintain a longer screen life.

2 Calibrated & Certified as per International Standards.

3 The screen shall be passivated, micro polished & treated to give a crevice free, smooth & non sticky surface.

4 The screen shall be easy to mount, use, wash & maintain.

5 Authentic certificates shall be provided with full traceability.

IN HOUSE CODING PROCEDURE FOR SIEVE & SCREEN

Sr.No. Type of sieve/screen In house coding details

1 Sifter sieves SISF/Mesh size/ Serial no.

For example:Frist sieve required for Vibro sifter having 40# procured in the year shall be coded as SISF/40#/001.

2 Multimill screen SCMM/Mesh size/ Serial no.

3 Comminuting mill screen SCCD/Mesh size/ Serial no.

4 Turbo sifter cum multimill screen

SCTM/Mesh size/ Serial no.

5 Oscillating granulator screen SCOG/Mesh size/ Serial no.

6 Co-mill screen SCQM/Mesh size/ Serial no.

7 Pot sieve PS/Mesh size/ Serial no.

INSPECTION OF NEW SIEVE

Visually inspect the new sieve for wire cloth weaving defects & Silicone molding defects:

Visually inspect the new sieve for integrity of wire cloth & silicon molding.

Wire cloth weaving defects such as: Broken hole, Broken wire, Weaving of impurity, Wire twisting, Wire doubling, Knot bulging etc.

Silicone molding defects such as: Excess flow of rubber which may creates cervices & shredding problems.

Tearing of rubber which may creates contamination & integrity problems.

Loose sieve-Lack of proper tensioning which creates output problems.


Check the diameter of sieve by using calibrated SS scale.

Wire mesh size: No. of opening per linear inches.

Measure the mesh size by using Liner mesh counter with magnification of 8X having graded slots of 1”,1/2”,1/4” & 1/8”.


Wire mesh size: No. of opening per linear inches.

Measure the mesh size by using Liner mesh counter with magnification of 8X having graded slots of 1”,1/2”,1/4” & 1/8”.

Sr.No. Mesh size No. of squares per linear inch= Mesh count

1 Upto 20# No.of squares in one inch =

2 Upto 60# No.of squares in 1/2 inches x 2 =




MOC of wire mesh shall be of SS 316 quality.

Verify MOC certificate for wire mesh provided by supplier.

Silicone molding :The edge of the wire mesh shall be molded with food grade quality, transparent & non-toxic silicone polymer . Check the new sieve for in house coding details.

The sieve shall be permanently labeled with the Manufacturers name, traceability code & date of manufacture. Verify MOC certificate for silicone molding provided by supplier.

Verify Calibration certificates provided by supplier.

INSPECTION OF NEW SCREEN

Visually inspect the new screen for integrity & welding quality.

Visually inspect the new screen for integrity of wire cloth ( in case of wire mesh screen supported by frame).

Check the dimensions of screen by using calibrated SS scale.

Check the thickness of screen by using calibrated vernier caliper. Check the new screen for in house coding details engraved on it.

The sieve should be permanently labeled with the Manufacturers name, traceability code & date of manufacture.

In case of wire mesh screen supported by frame lack of proper tensioning which creates output problems.

INSPECTION OF NEW SCREEN

MOC of screen shall be of SS 316 quality.

Screen size:Aperature size/pore size.

Check the aperature size/pore size by using GO/NO GO pins.

Verify MOC certificate for screen provided by supplier.

Verify Calibration certificates provided by supplier.

Sr.No. Screen size Pin size (mm) - GO/NOGO pins.

1 For example:5.00 mm

4.9 mm-should GO easily.5.0mm-should GO with little difficulty.5.1mm-should not go.(NOGO)

INVENTORY,CLEANING ,USAGE ,STORAGE & DESTRUCTION OF SIEVE/SCREEN

Record the details of receipt, inspection and coding of new sieve & screen in sieve/screen inventory record as per respective SOP.

Check the integrity of sieve/screen before & after use against the light.

Clean the sieve/screen by using soft & purified water as per respective SOP.

After cleaning dry it by using compressed air & lint free cloth.

Transfer cleaned sieve/screen in a polybag and affix "CLEANED" label on it.

Store clean ,dry and labeled sieve/screen in storage trolley/cabinet.

Destroy the damaged sieve/screen as per as per respective SOP.

Record the details of issuance ,usage, cleaning and destruction as per SOP.

VERIFICATION OF SIEVE/SCREEN CERTIFICATES

Manufacturer provides required MOC & calibration certificates along with new sieve/screen.

In housing coding details are mentioned in MOC & calibration certificates.

Verify MOC & calibration details in certificates provided by supplier.

SIEVE/SCREEN CERTIFICATES

At present we are purchasing sieves & screens from following manufacturers.

Pharmaspares : Website : www.pharmaspares.com E-mail ID :[email protected]

Atlanto Engineers : Website : www.atlanto.net E-mail ID :[email protected].


Certificates for wire mesh:

Sr.No Sieve/Screen MOC certificates for stainless steel

Manufacturer

Pharmaspares

Atlanto

1 Chemical analysis as per IS-228 of stainless steel & traceability data.

√ √

2 Traceability data for chemical analysis –IS- 228 √ X

3 Lead free certificate √ √


Sieve/Screen MOC & related certificates for silicone rubber:

Sr.No Sieve/Screen MOC & related certificates for silicone rubber

ManufacturerPharmaspares Atlanto

1 Food grade quality certificate as per requirement of FDA 21 CFR part 177.2600

√ √

2 Toxicology test report USP-32,NF 27-2009 √ √3 Silicone rubber technical data √ X4 Silicone rubber oxidation resistance data √ X5 Silicone rubber steam resistance data √ X

6 Silicone rubber chemical resistance data √ X7 Silicone rubber fungus resistance data √ X8 Silicone burst strength certificate X √


Sieve/Screen calibration certificates & TSE/BSE certificates:

Sr.No. Sieve/Screen calibration certificates ManufacturerPharmaspares Atlanto

1 Sieve/Screen validation data. √ √

2 International organization for standardization-9044 rating.

√ X

Sr.No. TSE/BSE certificates ManufacturerPharmaspares Atlanto

1 TSE/BSE certificates. √ √

INTERNATIONAL ORGANISATIONS/INSTITUTES

Manufacturer follows standard technical specifications & test procedures, technical reports specified by some International organizations/Institutes.

Sr.No. International organizations/Institutes

1 International Organization for Standardization (ISO) 2 American Institute of Steel & Iron (AISI)3 United States of Food & Drugs Administration (USFDA)4 United States Pharmacopeia (USP)5 American Society for Testing and Materials (ASTM)6 Deutsches Institut Für Normung

(German Institute for Standardization)7 Dow Corning Corp.

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

Purpose/focus :International standardization.

Formation: 23 February 1947.

Headquarters :Geneva, Switzerland.

ISO has 163 national members, out of the 203 total countries in the world.

Official languages: English, French and Russian.

Website:www.iso.orgThe organization which today is known as ISO began in 1926 as the International Federation of the National Standardizing Associations (ISA). ISO is a voluntary organization whose members are recognized standard authorities, each one representing one country.

The bulk of the work of ISO is done by the 2700 technical committees, subcommittees and working groups.

http://en.wikipedia.org/wiki/File:ISO_english_logo.svg

Type :NGO.

ISO defines itself as a non-governmental organization, its ability to set standards that often become law, either through treaties or national standards, makes it more powerful than most non-governmental organizations.

In practice, ISO acts as a consortium with strong links to governments.

ISO, is an international standard-setting body composed of representatives from various national standards organizations.The organization promulgates worldwide proprietary industrial and commercial standards.ISO's main products are the International Standards. ISO also publishes Technical Reports, Technical Specifications, Publicly Available Specifications, Technical Corrigenda and Guides.It was disbanded in 1942 during the second World War but was re-organized under the current name, ISO in 1946.

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

http://en.wikipedia.org/wiki/File:ISO_english_logo.svg

AMERICAN INSTITUTE OF STEEL & IRON (AISI)

Purpose/focus :Provides high-quality, value-added products to a wide array of customers; Lead the world in innovation and technology in the production of steel; Produce steel in a safe and environmentally friendly manner .AISI also plays a lead role in the development and application of new steels and steelmaking technology.

Formation: In 1908 American Iron and Steel Association is merged into American Iron and Steel Institute.Headquarters : Washington,USA.

AISI is comprised of 24 member companies, including integrated and electric furnace steelmakers and 140 associate and affiliate members who are suppliers to or customers of the steel industry.Website:www.steel.org.

http://en.wikipedia.org/wiki/File:Steelmark_logo.svg

UNITED STATES OF FOOD & DRUGS ADMINISTRATION.

FDA is an agency within the Department of Health and Human Services of US.

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, nation’s food supply, cosmetics and products that emit radiation and by regulating the manufacture, marketing, and distribution of tobacco products.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines, foods more effective, safer and more affordable.

Website: www.fda.gov

Food and Drug Administration,10903 New Hampshire Ave,Silver Spring, MD 20993-0002

http://en.wikipedia.org/wiki/File:Food_and_Drug_Administration_logo.svg

UNITED STATES PHARMACOPEIA (USP)

Purpose/focus :The United States Pharmacopeia Convention (usually also called the USP) is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year. Formation: 1820.

Headquarters : Rockville,Maryland,USA.

The United States Pharmacopeia (USP) is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF.

Prescription and over–the–counter medicines and other health care products sold in the United States are required to follow the standards in the USP-NF.

Website:www.usp.orgUSP also sets standards for food ingredients and dietary supplements.

AMERICAN SOCIETY FOR TESTING AND MATERIALS

Purpose/focus :ASTM International, formerly known as the American Society for Testing and Materials.ASTM is a globally recognized leader in the development and delivery of international voluntary consensus standards.Formation: ASTM was formed in 1898 by chemists and engineers . Headquarters : West Conshohocken, Pennsylvania,USA.Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade and build consumer confidence.ASTM International standards are the tools of customer satisfaction and competiveness for companies across a wide range of markets. Through 141 technical standards-writing committees, ASTM serves diverse industries ranging from metals to construction, petroleum to consumer products, and many more.Website:www.astm.org

http://en.wikipedia.org/wiki/File:Logo-ASTM.PNG

DEUTSCHES INSTITUT FÜR NORMUNG (GERMAN INSTITUTE FOR STANDARDIZATION)

Purpose/Focus :DIN is the German national organization for standardization and is that country's ISO member body. DIN is a Registered German Association (e.V.).

Formation: Founded in 1917 , In 1975 it was renamed again to Deutsches Institut für Normung, or 'DIN' and is recognized by the German government as the official national-standards body, representing German interests at the international and European levels.Headquarters : Berlin. Germany.There are currently around thirty thousand DIN Standards, covering nearly every field of technology.DIN EN # is used for the German edition of European standards.DIN ISO # is used for the German edition of ISO standards. DIN EN ISO # is used if the standard has also been adopted as a European & ISO standard.Website:www.din.de

http://en.wikipedia.org/wiki/File:DIN-Logo.svg

DOW CORNING

Dow Corning is a multinational corporation.

Dow Corning specializes in silicon and silicone-based technology, offering more than 7,000 products and services. Dow Corning is an equally-owned joint venture of Dow Chemical and Corning.Silastic is a trademark registered in 1948 by Dow Corning Corporation for flexible, inert silicone elastomer. Today, the Silastic trademark refers to silicone elastomers, silicone tubing and some cross-linked polydimethylsiloxane materials manufactured by Dow Corning, the owner of the global trademark.

Formation: Founded in 1943.Headquarters : Midland, Michigan.USA.Products:Speciality Chemicals, silicon derived polymers.Revenue: $5.09 billion(2009),Employees more than 10,000.Website:www.dowcorning.com

http://en.wikipedia.org/wiki/File:Dow-Corning-Logo.png

USFDA:CODE OF FEDERAL REGULATIONS (21CFR PART-211)

21 CFR: Part 211

Subpart D—Equipment

211.63 Equipment design, size, and location.

211.65 Equipment construction.

211.67 Equipment cleaning and maintenance.

211.65 Equipment construction.

(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

CHEMICAL ANALYSIS OF STAINLESS STEEL

The elemental analysis falls within the specified parameters for AISI SS316 quality with respect to the elements tested.

Sr.No SS Grade

Min/Max C Cr Mn P S Si Ni Mo

1 AISI

304

Min - 18.0 - - - - 8.0 -

Max 0.08 20.0 2.0 0.045 0.03 1.0 10.5 -

2 AISI 316

Min - 16.0 - - - - 10.0 2.0

Max 0.08 18.0 2.0 0.045 0.03 1.0 14.0 3.0

3 AISI

316 L

Min - 16.0 - - - - 10.0 2.0

Max 0.03 18.0 2.0 0.045 0.03 1.0 14.0 3.0

TRACEABILITY DATA FOR CHEMICAL ANALYSIS –IS- 228

MOC of product contact parts is very important concern.

Chemical composition of stainless steel 316 is similar to SS 304 except that SS 316 has 2% less Chromium, 2 to 4% higher Nickel content & 2 to 3% Molybdenum.

The Molybdenum gives improved resistance to corrosion.

Chemical analysis of stainless steel content of the sieves/screens supplied was carried out as per I.S.228:1987 test.

This method has been cross referred to ISO/TR:1900 Steel & Iron review of available method of analysis.

Traceability data for chemical analysis shall be specified in required certificate.

LEAD FREE CERTIFICATE

Lead is poisonous metal that can damage nervous connections especially in young children's and cause nephropathy and colic like abdominal pains.

Manufacturing process of sieve/screen shall not involve the use of any toxic Lead or Tin solders or any Lead containing alloys.

Manufacturer must certify that all the parts coming in contact with drug products are Non-Toxic.

Testing kits are commercially available for detecting lead. These swabs, when wiped on a surface, turn red in the presence of lead.

http://en.wikipedia.org/wiki/File:Lead_testing.jpg

FOOD CONTACT STATUS AND FDA REGULATIONS AS PER FDA 21 CFR 177.2600 (d-h)

.

Food contact status and FDA regulations as per FDA 21 CFR 177.2600 (d-h)Sr.No FDA 21 CFR 177.2600 (d-h).

1 Subchapter b--Food for human consumption

Subpart B--Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces.

Part 177 -- Indirect food additives: polymers.

Sec. 177.2600 Rubber articles intended for repeated use.2 Rubber articles intended for repeated use may be safely used in

producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

3 (d) Rubber articles intended for use with dry food are so formulated and cured under conditions of good manufacturing practice as to be suitable for repeated use.


4 (e) Rubber articles intended for repeated use in contact with aqueous food shall meet the following specifications:

The food-contact surface of the rubber article in the finished form, in which it is to contact food, when extracted with distilled water at reflux temperature, shall yield total extractives not to exceed 20 milligrams per square inch during the first 7 hours of extraction, nor to exceed 1 milligram per square inch during the succeeding 2 hours of extraction.

5 (f) Rubber articles intended for repeated use in contact with fatty foods shall meet the following specifications:

The food-contact surface of the rubber article in the finished form, in which it is to contact food, when extracted with N-hexane at reflux temperature, shall yield total extractives not to exceed 175 milligrams per square inch during the first 7 hours of extraction, nor to exceed 4 milligrams per square inch during the succeeding 2 hours of extraction.


Pharmaspares:Certificate No:TC/475/2010 dated on 06/08/2010,

Batch No.MSO4666 & Traceability No.PC/D/09074.Sr.No Procedure Residue Limit for 645mm²

1 Extraction with Distilled water

(After 7 hours)

4.05 mg Max.20.0 mg

2 Extraction with Distilled water

(After 2 hours)

0.35 mg Max.1.0 mg

3 Extraction with N-Hexane

(After 7 hours)

31.28 mg Max.175.0 mg

4 Extraction with N-Hexane

(After 2 hours)

1.11 mg Max.4.0 mg


Food contact status and FDA regulations as per FDA 21 CFR 177.2600 (d-h).

6 (g) In accordance with good manufacturing practice finished rubber articles intended for repeated use in contact with food shall be thoroughly cleaned prior to their first use in contact with food.

7 (h) The provisions of this section are not applicable to rubber nursing-bottle nipples.

SILICONE BASIC POLYMER AS DESCRIBED IN ASTM D1418-81.

The silicone basic polymer as described in ASTM D1418-81.

Sr.No

ASTM D1418-81.

1 ASTM D1418 - 10a : Standard Practice for Rubber and Rubber Latices-Nomenclature.

2 This practice covers a system of general classification or nomenclature for rubber and rubber latices.

Rubbers in both dry and latex form shall be coded from the chemical composition of the polymer chain using the classes.

TOXICOLOGY TEST REPORT AS PER USP 32, NF27, 2009

Reference: USP 32, NF27, 2009,<88> Biological Reactivity Tests in vivo.

The silicone rubber extracts were injected systematically and intracutaneously in mice. Including further dilution of the extracts prepared with PEG.

The animals were observed for signs of toxicity and skin reactivity for upto 72 hours post treatment.

In addition, the test article was implanted into the paravertebral muscles of rabbits for 7 days.

Observed for signs of hemorrhage,necrosis,discolouration,encapsulation and infection.

Silicone rubber article must meets the requirements of the Biological reactivity tests in vivo for plastics Class VI-70º.

SILICONE RUBBER TECHNICAL DATA CERTIFICATE

To check the silicone rubber resistant to twisting stress. Cut specimen is tested under severe twisting stress.

Technical data Test Method Unit Measured value

Lower limit

Upper limit

Viscosity DIN 52523 No unit 65 45 75Density DIN EN ISO

1183-1 Ag/cm³ 1.18 1.16 1.20

Hardness DIN 53505-A No unit 70 66 74

Tensile Strength

DIN 53504-SI N/mm² 113 90 130

Elongation DIN 53505-SI % 471 300 600

Tear Strength ASTM D 624 B N/mm 26.4 19.0 35.0

SILICONE RUBBER OXIDATION RESISTANCE DATA

Sr.No. Silicone Rubber Oxidation Resistance Data.

1 Sieves are resistant to oxidative damage. 2 Oxidation which can quickly destroys the organic elastomers.3 Silicone rubber when tested for resistance to ozone should shows

excellent stability.4 After both static and dynamic testing for periods of two, four, six and

eight hours, samples had no significant change in durometer hardness, tensile strength, or elongation. Under a magnification of 10, no cracking or checking was visible.

5 The test procedures followed procedures of ASTM D518 and ASTM D1149.

6 ASTM D518:

Test procedures include effect of ozone on silicone elastomers to observe cracking.



7 ASTM D1149 - 07 Standard Test Methods for Rubber Deterioration-Cracking in an Ozone Controlled Environment:

The significance of these test methods lies in the ability to differentiate between the degrees of ozone resistance under the limited and specified conditions of the accelerated tests.

The degree of resistance being judged by the appearance and magnitude of the formation of cracks in the surface of the subject material.

In service, rubber materials deteriorate when exposed to ozone.

Previously published ASTM documents Test Method D 518 and Test Methods D 3395 have been included in these test methods, D 1149, in 2007. Please refer to Note 2.



7 ASTM D1149 - 07 Standard Test Methods for Rubber Deterioration-Cracking in an Ozone Controlled Environment:

1.2.1 Test Method D 518 and Test Methods D 3395 have henceforth been withdrawn and superseded by Test Methods D 1149.

1.3 The specified conditions of exposure to ozone in the controlled environments are accelerated in comparison to outdoor exposure..

Concentration of 50 parts of ozone per 100 million parts of air is specified. For silicone rubber this concentration increased up to 30000 parts of ozone. This procedure also states that a temperature of 40 or 50 degree may be used.

Silicone rubber is tested successfully at 74 degree.

SILICONE RUBBER STEAM RESISTANCE DATA

In general, Silicone rubber (not under pressure) is little affected by moisture in the form of free steam.

This is also true when the steam is at low or moderate pressure.

However, with increased steam pressure, affects upon the mechanical properties of the rubber become greater.

As a rule, silicone rubber is not recommended for long term service where steam pressure exceeds 50 psi.

SILICONE RUBBER STEAM RESISTANCE DATA

Properties of general purpose silastic rubber after contact with steam

Contact Conditions Swell, percent Durometer Hardness Shore

A-2, points change 14 days/5 psi (720 Mpa) +3 -5

14 days/10 psi (1450 Mpa) Nil -5

14 days/20 psi (2900 Mpa) +4 -8

3 days/50 psi (7250 Mpa) +2 -47 days/50 psi (72500 Mpa) +9 -17

1 day/100 psi (14500 Mpa) +3 -8

7 days/100 psi (14500 Mpa) +13 -35

SILICONE RUBBER CHEMICAL RESISTANCE DATA

Sr.No Reagent Siliastic silicone rubber volume change: percentage

1 Acid solution (tested 7 days at room temperature)10% Percentage Hydrochloric Acid 0 to 2Concentrated Hydrochloric Acid 0 to 1510% Nitric Acid 1 to 10Concentrated Nitric Acid -10 to -510% Sulfuric Acid 1 to 5Concentrated Sulfuric Acid decomposedConcentrated Acetic Acid 5 to 18

2 Alkali solutions (Tested 7 days at room temperature)10%Ammonium hydroxide NilConcentrated Ammonium hydroxide 0 to 710% Sodium hydroxide 0 to 350% Sodium hydroxide 0 to 9

SILICONE RUBBER CHEMICAL RESISTANCE DATA

Sr.No Reagent Siliastic silicone rubber

volume change: percentage

3 Solvents & Fuel (Tested 7 days at room temperature)

Acetone 15 to 25

Carbon Tetrachloride Over 150

Ethyl Alcohol 0 to 20

Iso-Octane Over 150

Xylene Over 150

Reference fuel B Over 150

Jet fuel JP-4 Over 150

SILICONE RUBBER FUNGUS RESISTANCE DATA

Sieves must be resistant to Fungal growth.

When rubber is used in any warm, damp environment, its properties must resist attack by mold or fungus.

Although silicone rubber is not ant fungicidal.

It is not a nutrient for fungi nor is it adversely affected by fungus or mold.

Test procedure described in 005272 B (USAF) several classes of Military Specification MIL-E: Fungus Resistance :

When rubber is used in any warm, damp environment, its properties must resist attack by mold or fungus. Although Silastic® silicone rubber is not ant fungicidal, it is not a nutrient for fungi nor is it adversely affected by fungus or mold.

SILICONE RUBBER FUNGUS RESISTANCE DATA

With test procedures described in 005272B (USAF), several classes of Military Specification MIL-E, Silastic silicone rubber was exposed to chaetominum, globum, aspergillus niger, aspergillus terreus, penicillium lutem, and fusarium moniliforne. None of these micro-organisms deteriorated the specimens.

In another test, Silastic silicone rubber samples were buried in 5 inches of warm (28°C) moist soil for 6 weeks with no evidence of microbial attack.

In a third test, samples were sprayed with a mixed spore suspension of fungi and then placed in a tropical test chamber at 27°C, 90/100 percent relative humidity. None were attacked by mildew.

SIEVE VALIDATION DATA

The stainless steel wire mesh is checked for the mesh count as per ISO-4783-1-1989(E)-6.

The diameter of the wire is checked as per ISO-9044-1999-5.1. Tolerance as per ISO-4782.

The nominal aperture size is determined as per ISO-9044-1999-5.2.1.2 or ISO- 9044-1999-5.2.1.3 .

Tolerance as per ISO-9044-1999-Table-1.

The wire mesh is riveted to the steel frame using aluminum rivets.

The sieves are then molded with a pure, non-toxic, food grade silicone polymer.

SIEVE VALIDATION DATA

Procedure Instrument Traceability

Mesh count-ISO-4783-1-1989(E)-6 Combined Eye Glass

CAL/3117-09/10

Wire Diameter –ISO-9044-1999-5.1

Tolerance as per ISO-4782.

Digimatic Caliper

NMIJ/AIST by JCSS,Identification code:3903209348

Micron rating - ISO-9044-1999-5.2.1.2 or ISO-9044-1999-5.2.1.3

Tolerance as per ISO-9044-1999-Table-1.

Computerized Digital Microscope

Code No.-00022911

Calibrated Stage Micrometer

IDCC,Identification Code:01001401/SM10/100/1.

SCREEN VALIDATION DATA

Dimensions of opening: Individual holes are checked for compliance with ASTM-E-674-80(2004) X3.2.

The tolerances on the measured average nominal aperture size is measured as per: ASTM-E-674-80(2004) X1.1-Table-2.

Measurement of pitch of the aperture: The pitch of the apertures is checked & compared as per ASTM-E-674-80(2004) X3.4, Dimensions of bars. Tolerances as per Table-3.

The perforated plate is welded and micro polished to give smooth crevice free surface.

Instruments for measurement are calibrated calipers with traceability to Mitutoyo-CD-8”CSX code No:500-197-20,Sr no:06589594 & digital image analysis with traceability to IDDC & NPL.

TSE/BSE FREE CERTIFICATE

Transmissible spongiform encephalopathies (TSEs) are a family of diseases of humans and animals characterized by spongy degeneration of the brain with severe and fatal neurological signs and symptoms.

Transmissible spongiform encephalopathies (TSEs), also known as prion diseases, are a group of progressive conditions that affect the brain and nervous system of many animals, including humans.

Mental and physical abilities deteriorate and myriad tiny holes appear in the cortex causing it to appear like a sponge (hence 'spongiform') when brain tissue obtained at autopsy is examined under a microscope.

The disorders cause impairment of brain function, including memory changes, personality changes and problems with movement that worsen over time.

Prion diseases of humans include classic Creutzfeldt–Jakob disease, new variant Creutzfeldt–Jakob disease (nvCJD, a human disorder related to mad cow disease, Gerstmann–Sträussler–Scheinker syndrome.


Bovine spongiform encephalopathy (BSE) is also a TSE, affecting a number of species (cattle, human, cats, some types of animals in 300 settings). BSE is a transmissible, neuro-degenerative fatal brain disease of cattle. The disease has a long incubation period of 4-5 years and it is fatal for cattle within weeks to months of its onset. The nature of the BSE agent is still being debated.

It is transmitted through the consumption of BSE-contaminated meat and bone meal supplements in cattle feed.

Prions cannot be transmitted through the air or through touching or most other forms of casual contact.

However, they may be transmitted through contact with infected tissue, body fluids, or contaminated medical instruments.


Classic image of a cow with BSE:

A feature of such disease is the inability of the infected animal to stand.


Manufacturer of sieve/screen must certify that there are no animal constituents used during the manufacturing of sieve/screen. Product is created through chemical process. It does not contains any Bovine spongiform encephalopathy (BSE) , Transmissible spongiform encephalopathies (TSEs),Gluten or any other type of genetically modified microorganisms.

Dark green areas are countries with confirmed human cases of vCJD.

Light green shows countries which have reported cases of only BSE.

AUDIT PREPARATION FOR SIEVES/SCREENS

Available sieves & screens shall be checked for its integrity, intactness of

silicone gasket, rusting, stains, physical appearance or any other defects.Any sieve & screen having such defects shall destroy as per procedure described in respective SOP.Sieve & screen specification, procurement, inventory, coding, cleaning, storage, inspection & destruction procedure shall be described in respective SOP.Calibrated sieve & screen inspection kit shall be available along with certificates.Each instrument in sieve/screen inspection kit shall be coded as per procedure described respective SOP.Sieve & screen inventory, inspection, usage & destruction record shall be maintained.Coding of sieve & screen shall be done as per procedure described in respective SOP.

AUDIT PREPARATION FOR SIEVES/SCREENS

Coding of sieve & screen shall be done as per procedure described in respective SOP.Sieve & screen certificates shall be available in its storage room. Numbering of sieve & screen shall be mentioned in certificates provided by manufacturer.Sieve & screen storage trolley/cabinet shall be checked for its cleanliness.Cleaned Sieves & screens shall be stored with proper labeling.Sieve & screen coding mentioned in previous BMRs to be checked.Training shall be imparted to the concern persons engaged with above activity & records for the same shall be maintained.Concern person engaged in sieve & screen inspection shall be able to explain the inspection procedure in front of auditors.Pot sieves used for the filtration of coating solution shall be maintained as per above procedure. Sieve /screen issuance & retrieval record shall be maintained.

sieve & screen used in pharmaceutical manufacturing

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