draft product certification manual for comments · doc no: cmd/1061/draft manual page 2 draft...

Doc No: CMD/1061/Draft Manual

DRAFT PRODUCT CERTIFICATION MANUAL FOR COMMENTS

Our Ref.CRO 22 / BPBO 19 Dec 2013 Please find enclosed the following draft certification manual:

DISINFECTANT FLUID, PHENOLIC TYPE AS PER IS 1061 Kindly examine the draft product certification manual and forward your comments on the draft manuals. Last date for comments: 30 Dec 2013. Comments, if any, may please be made in the format as given below and mailed to BPBO (Bhopal) at the following email id: hbplbo.bis

Sl. No.

Name of RO / BO

Clause/ Sub‐clause

Paragraph / Figure / Table

Type of comment (General / Technical / Editorial)

Comments Proposed Change

Note: Separate sheets may be attached incase comments are lengthy and cannot be incorporated in the


DRAFT MANUAL FOR

CERTIFICATION OF DISINFECTANT FLUID, PHENOLIC TYPE AS PER IS

1061

(FIRST ISSUE)

BUREAU OF INDIAN STANDARDS MANAK BHAWAN, 9, BAHADUR SHAH

ZAFAR MARG, NEW DELHI – 110002


Amendment Sheet S.No. Amendment No Reference no Date of Issue Date of implementation


FOREWORD The present manual attempts in highlighting various requirements and providing handy and significant information related to “Disinfectant Fluid, Phenolic Type”. It elaborate principle raw materials, manufacturing processes and desired controls, involved inspection and testing as need be practiced by BIS licencees and further monitoring thereof expected to be exercised by BIS Inspecting Officials during planned visits to those units and monitoring of BIS Certification Marks activities. Different tests as contained in relevant standards and referred standards thereof need be carried out at the licensee’s laboratory by the visiting officer with knowledge and background possessed by the individual. Since such inspecting officers come from different educational and technical background and may not be experienced or even having basic knowledge in the relevant field or product category, such documentation of sectoral manual aims in providing basic inputs and all essential aspects with the expectation of bringing uniformity of vision and enabling adoption of rational practices by concerned BIS officials during their visits for inspections to such sector as well as follow up actions.


TABLE OF CONTENTS Section No/ Para No

Title Page no

0 Amendment Sheet 2 0 Foreword 3 Section 1.0 Product Description 6-7 Para 1.1. Latest Indian Standard Number with Product Title and

Number of Amendments 7

Para 1.2 List of referred Indian Standards 7 Para 1.3 Check-list for submission of an application for grant

of licence 7

Section 2.0 Raw materials/ Components 8 Section 3.0 Manufacturing Process and In- Process Quality

Controls 9

Para 3.1 Manufacturing Process 9 Para 3.2 Infrastructure for production 9 Section 4.0 Certification criteria 10-11 Para 4.1 Identification of Critical Requirements of the Indian

Standard 10

Para 4.2 Scheme of Testing and Inspection 10 Para 4.3 Marking fee Rates 10 Para 4.4 Grouping guidelines 10 Para 4.5 Guidelines for writing Scope of Licence 11 Para 4.6 Guidelines for inclusion of new varieties 11 Para 4.7 Sample size required to be sent to independent lab for

testing 11

Para 4.8 Manner of sealing of samples 11 Para 4.9 Procedure of disposal of remnants of Tested Samples 11 Para 4.10 Procedure to be followed if sample does not meet the

specified norm as per Indian Standard during regular production

12

Section 5.0 Inspection and Testing 13-14 Para 5.1 Packing Material for packing/dispatch of samples 13 Para 5.2 List of test equipment/ Facilities with requirement and

frequency of Calibration 13

Para 5.3 Status of Test Facilities in BIS labs/OSLs 13 Para 5.4 Grant of Licence 13 Para 5.5 Details of tests to be carried out in the factory 13


Appendix-A --------- Check list for submission of an Application for Grant of Licence Appendix-B --------- Flow Chart Appendix-C --------- List of Manufacturing Machinery Appendix-D --------- Scheme of Testing and Inspection


SECTION – I 1.0. Description of product: Disinfectant fluids are applied to destroy microorganisms that are living on the nonliving objects. Disinfectants work by destroying the cell wall of microbes or interfering with the metabolism. Phenol is probably the oldest known disinfectant which is found in most of the household disinfectants. 1.1. Latest Indian Standard Number with Product Title and Number of Amendments: Latest Standard: IS 1061:1997 Title: Disinfectant Fluid, Phenolic Type No. of Amendments: 03

1.2 List of referred Indian Standards for raw materials/ components and test methods: The following standards contain provisions which through reference in this text, constitute provisions of this standard. At the time of publication, the editions indicated were valid. All standards are subject to revision and parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below: IS No. Title 878:1975 Graduated Measuring Cylinders (first revision) 1070:1992 Reagent grade water (third revision) 4905:1968 Method of random sampling 6850:1973 Agar, microbiological grade 6851:1973 Meat extract, microbiological grade 6853:1973 Peptone, microbiological grade 8770:1978 Artificial sea water for laboratory use


1.3 Check-list for submission of an application for grant of licence: Please see Appendix-A


SECTION – II 2.0 List of Major Raw Materials:

a) Castor oil, b) Rosin, c) Caustic soda d) Light Creosote oil or Coal tar acids/similar acids derived from petroleum e) Chlorinated Phenols and Xylenols f) Soft water g) Pine oil


SECTION – III 3.0 Manufacturing Process and In-process Quality Controls: 3.1 Manufacturing Process: The generalized manufacturing process of Disinfectant Fluid consist of 2 stages a) Preparation of Soap Solution (Emulsion) b) Mixing of antimicrobial compound in the emulsion. A generalized flow chart with process controls points given at Appendix-B 3.2 Infrastructure for production: Please see Appendix-C


SECTION – IV

4.0 Certification Criteria 4.1 Identification of Critical Requirements of the Indian Standard: (To be provided by a committee comprising the concerned officer from CMD, Member-Secretary of the concerned technical committee and an officer from central laboratory) 4.2 Scheme of Testing and Inspection: DOC: STI/1061/6, July 2002 (Please see Appendix-D) 4.3. Marking fee Rates: Manufacturing Status of Industry

Minimum marking fee per year

Unit Unit rate

Large Scale Rs. 34000/- 1 Kilo Litre Rs. 43.2/- for all units Small Scale Rs. 29000/- 1 Kilo Litre Rs. 43.2/- for all units 4.4 Grouping guidelines: There is no grouping guidelines exists as on date to consider Grant of license/inclusion of new varieties for this product. Therefore, the proposed grouping guidelines are as under: In all three grades of each class of disinfectant fluid specified in IS 1061, Grade 1 is the most superior grade and Grade-3 is the inferior grade. The following group may be considered

Class- Black, Grade – 1,2,3 Group 1 Normal Class- White, Grade – 1,2,3 Class- Black, Grade – 1,2,3 Group 2 Winter Class- White, Grade – 1,2,3

If a sample get tested for superior grade of any class (Black or White) of a group, all the class and grades of the group may be considered for Grant of licence/ inclusion of new varieties. (For example, if sample of Normal type, Class Black and Grade 1 disinfectant fluid get tested, grant of license/ inclusion of new variety may be considered for Normal type, Class Black, Grade 1,2 and 3 and Class white, Grade 1,2 and 3, if a sample of Normal type, Class Black and Grade 2 disinfectant fluid get tested, grant of license/ inclusion of new variety may be considered for Normal type, Class Black, Grade 2 and 3 and Class white, Grade 2 and 3 only). .


4.5 Guidelines for writing Scope of Licence: Scope of the license shall contain, Class, Grade and Type of the Disinfectant fluid. 4.6 Guidelines for inclusion of new varieties: Please see para 4.4 above 4.7 Sample size required to be sent to independent lab for testing: For complete testing 3 numbers of individual closed containers of 500 ml disinfectant fluid (3 x 500ml) is required. It shall be ensured that the size of the sample is adequate for testing (and retesting wherever needed) the requirements for which it is desired to be tested. The technical auditor shall anticipate all requirements of the laboratory on the basis of' the relevant Indian Standards and STI, and draw the required size of the sample. Counter samples of identical size shall be drawn and left with the applicant / licensee. 4.8 Manner of sealing: 4.8.1 Sealing - The individual containers (3 nos x 500ml) shall be closed firmly and properly sealed with official seal on the joint between bottle and the cap so that no substitution or tampering with the contents is possible subsequently. For the purpose of sealing, the technical auditor should always carry the brass seal. 4.8.2 Packing - The technical auditor shall take every precaution to ensure that the sealed samples (3 x 500 ml) is packed firmly in a durable packing material like wooden cardboard or carton box with expanded polystyrene or any other shock absorbing material to withstand hazards during handling and transportation. Wherever feasible, all original markings indicating the origin of the product would be removed / defaced from the sample with the objective of concealing the identity of the origin from the testing laboratory. 4.8.3 Labelling - The sample shall be labeled to indicate (a) Disinfectant fluid; (b) the relevant Indian Standard with its year (IS1061:1997);(c) class; (d)grade; (e)type; (f) quantity of sample(3 x 500ml); (e) batch No./Control Unit No./date of production; (f) Shelf life of the product (shall be declared by the manufacturer), (g) Sample code. Labels shall be tagged to the sample or on the Packing. 4.9 Procedure of disposal of remnants of Tested Samples: These remnant samples are non returnable and shall be disposed off. 4.10 Procedure to be followed if sample does not meet the specified norm as per Indian Standard during regular production:


In case of sample does not meet the requirements specified in Indian standard, such control unit i.e. Batch/lot shall not be marked. Those rejected batches/lots shall be destroyed.


SECTION – V 5.0 Inspection and Testing 5.1 Packing Material: The following material should always be available with the firm for packing, sealing and dispatch of samples: Glass bottles-500 ml(minimum 6 no’s), Wooden card board box or Carton box, Expanded polystyrene, Air bubble roll, Wax coated plain envelops, Thread, Sealing wax, Candle, Match box, Gum, Stapler, Nails, Hammer, Sealing tape, etc. 5.2 List of test equipment/ Facilities with requirement and frequency of Calibration: (To be prepared / provided by Central Laboratory) 5.3 Status of Test Facilities in BIS labs/OSLs: Technical auditor shall ensure status of laboratory and availability of testing facilities at the time of visit from BIS intranet. 5.3.1 Testing Charges: (To be provided by Central Laboratory) 5.3.2 Approximate time required for testing by BIS labs/OSLs: (To be provided by Central Laboratory) 5.4 Grant of Licence: Grant of licence would be on the basis on independent testing. 5.5 Details of tests to be carried out in the factory: 5.5.1 In case of Applicant/Verification samples:

a) Composition and Description (Clause 4.1) b) Stability after Dilution (Clause 4.2) c) Germicidal values (Clause 4.3) d) Mercury compound (Clause 4.4) e) Stability on storage (Clause 4.5)

5.5.2 In case of Surveillance samples: Technical auditor shall conduct maximum possible tests in order to bring out any deficiencies in test equipment/testing procedures and testing personnel as well as for spot establishment of quality of product


5.5.3 In case of Market samples: The laboratory shall conduct maximum possible tests in order to asses’ quality of the product. 5.5.4: In case of Raw Material: Not applicable for this product


APPENDIX-A

CHECK-LIST FOR APPLICATION TO BE SUBMITTED BY APPLICANT TO

BIS WHILE APPLYING FOR BIS LICENCE UNDER PRODUCT CERTIFICATION SCHEME OF BIS

The following check-list is required to be submitted with all the applications for grant of BIS licence under the Product Certification Scheme of BIS. Please tick (√) in the relevant box. Whether applied under: Simplified Procedure Normal Procedure Note: Refer BIS website or details of “Simplified Procedure” and “Normal Procedure” for grant of licence.

No. Check-point Requirement Observations Page No.

General Is the application form completely filled? Name &

Address

Is the name and address of applicant (manufacturing unit applying for licence) same in the application as given in the attached document of Central/State Government

a. Has it been indicated whether the applicant is a large scale or small scale unit?

b. In case the applicant is a small scale unit, does the applicant hold valid Registration Certificate from the Local / State authority or from a Chartered Accountant, and is the certificate attached.

Status of Applicant (Manufacturing Unit)

c. Has it been indicated whether the applicant is a Public Sector or a Private Sector company?

a. Has applicant recorded the applicable Indian Standard with correct title of the Standard?

IS No. & Varieties

b. Where applicable, has applicant mentioned designation, grade, type, variety, size, etc., of the product for which the BIS licence is sought?

a. Where applicable, has the applicant provided information regarding earlier BIS licence(s) held by them and / or cancelled in the past?

History

b. Where applicable, has the applicant provided information regarding BIS licences currently held by them?


a. Is the application signed by the CEO of the applicant?

Signature

b. In case the application is signed by a person other than the CEO, is the application signed by the authorized signatory of the applicant and his authorization is attached by the authorized signatory?

a. Does applicant possess requisite manufacturing infrastructure to manufacture the product as per the Indian Standard?

b. Is installed capacity of production indicated in the application?

c. Does applicant have all machineries installed as per manufacturing process at the applicant’s manufacturing premises?

d. If answer to ‘c’ above is no, does the applicant outsource any of its manufacturing processes and possesses valid agreement(s) with other manufacturing units for the outsourced processes and traceability of material, thus produced, etc.?

Machinery

e. If answer to‘d’ above is yes, does the applicant has any control over such outsourced activity? Are these outsourced process will ensure testing the quality of final product for all requirements at the applicant's manufacturing premises?

a. Does applicant possesses requisite test facilities in-house as per the relevant Indian Standard at its factory address?

b. Are valid calibration certificates for relevant test equipment attached are complete and valid at least 3 months after the date of recording?

Test Equipment & Calibration

c. If reply to ‘a’ above is no, does applicant have arrangement with a BIS recognized outside lab for testing of the requirements for which it does not possess test facilities in-house? Is the consent letter as attached by applicant in this regard in order? Note: Relaxation in in-house test facilities may be allowed on submission of proper justification


for requirements which are obligatory to get tested and for which frequency of testing, as prescribed in the relevant scheme of testing and inspection (STI),is, normally, one month or more.

QC personnel Does the applicant employ qualified & experienced Quality Control (QC) personnel on permanent basis and possess documentary evidence to establish the same? Are the copies of the qualification certificates and appointment letters of the QC personnel are in order

Raw Materials and Components

Where ever requirements for raw materials/ components used in the manufacturing of the product are specified in the standard, do test reports/suppliers’ test certificates, as submitted by the applicant show that these requirements are met as per the standard?

Plant Layout Does copy of the plant (applicant manufacturing premises) layout clearly indicates locations of manufacturing machinery, laboratory, office, workshop, amenities, storage area, etc.?

a. Is the attached test report of in-house or from independent laboratory cover all requirements of the Indian Standard and is passing in such requirements?

Test Report(s)

b. In case the application is filed under “simplified Procedure” is the test report(s), in original, as submitted a) from BIS or its recognized laboratories? b) the test report is not older than one month from the date of submission of application, c) covers all the requirements of the standard, and d) passes in all such requirements.

Undertaking In case application is under simplified procedure, an undertaking shall be obtained from the applicant on his letter-head that the licence if granted against his application shall be put under Stop Marking by BIS if the verification sample(s) (any sample including the long duration test samples) drawn during visit of the BIS officer prior to grant of licence fail to conform to the requirements of relevant Indian Standards. The licensee shall take necessary


corrective actions and inform the same to BIS along with fresh samples (of rating/size/variety which facilitates verification of corrective actions on the reported failures) manufactured after taking the corrective actions. The resumption of marking in such cases shall be allowed only on the basis of independent satisfactory Test Reports of the fresh samples offered (including long duration tests where failures were in long duration tests). In case the fresh sample drawn by BIS for independent testing fails, or the licensee does not inform corrective actions taken and does not offer improved samples within 1 month of the date of Stop Marking, the licence shall be processed for cancellation and no further chance would be given to the licensee

Application Fee

Has applicant paid requisite application fee of Rs. 1000/-, in equivalent US$ (Rs. 1000/- plus 12.36% tax for applicants from SAARC countries)?

Signature Is the application countersigned by the applicant’s Authorized Indian Representative?

a. Has ‘Nomination Form’ of ‘authorized Indian representative (AIR)’ in the prescribed format on the firm’s letter-head, duly signed by the authorized signatory of the applicant and the AIR or the authorized person of the company of the AIR, been submitted with the application?

b. Is the authorization to the signing authority to sign the ‘Nomination Form’ on behalf of the Indian Co. also submitted?

c. Is address of the AIR in the ‘Nomination Form’ complete and evidence of nationality, address proof, contact details like phone / fax numbers and e-mail address of the AIR submitted?

Nomination

d. In case AIR is an Indian company, have copies of registration certificate and/or Memorandum of Articles along with authorization letter from top management of the Indian company in the name of a person acting as the AIR also been submitted with the


application? e. Has copy of Agreement between applicant and the Indian company / individual, nominated as the AIR, also been submitted?

f. Are copies of valid RBI clearance certificate for Indian Office / Branch of the applicant or any other relevant document for establishment of its Office / Branch in India provided?

Language Are English translations of all the documents, which are in languages other than English, also available?

Preliminary Inspection / Visit Charges

Does the applicant undertake to bear inspection charges for all the inspections to be carried out by BIS at its premises before the grant of licence, including the arrangements and costs incidental thereto for travel and stay, visa, insurance, etc.?

Translation Facility

Does the applicant undertake to arrange, if required, services of translator (for translation in English) during the visits of BIS officers to its factory?

Agreement Does the applicant agree to sign a legally binding agreement with BIS in the prescribed format?

Indemnity Bond

Does the applicant agree to submit an Indemnity Bond to BIS in the prescribed format?

Performance Bank Guarantee

Does the applicant agree to furnish a Performance Bank Guarantee to BIS of US $ 10000/- (from a bank having its branch in India) in the prescribed format on the letter-head of the bank?


Castor oil and Rosin

Mixing of preheated castor oil, rosin in

caustic soda at 60 oC

Caustic soda flakes

Soap Solution

For Black type Phenolic compouds,

Light creasol oil and tar acids

Marking as per ISS

Pass

* testing of raw materials

* weighing of raw materials

After 20 – 30 min

Soft Water


For White type Phenolic

compouds,Pine oil

Mixing tank fitted with Stirrer

Filling of disinfectant fluid in drums/bottles

Final testing as per

IS1061:1997

FailReject


* In process controls

APPENDIX-B


APPENDIX-C

S No

Name of Machine/Qty. Capacity Make Date of purchase

Quantity

1 Stainless steel tanks fitted with heating arrangement and stirrer

2 Measuring containers

3 DM water & softener Plant 4 Preparation tanks with motors / stirrer 5 Weighing machines 6 Filling machines 7 Transfer pumps 8 Fire extinguishers


APPENDIX-D Doc:STI/1061/6

July 2002

SCHEME OF TESTING AND INSPECTION FOR CERTIFICATION OF

DISINFECTANT FLUID, PHENOLIC TYPE ACCORDING TO IS 1061:1997

(With Amendment No.1) 1.0 LABORATORY: A laboratory shall be maintained which shall be suitably equipped and staffed where different tests given in the specification shall be carried out in accordance with the method given in the Table 1. 1.1 All testing apparatus shall be periodically checked and calibrated and records of such checks/calibration shall be maintained. 2.0 TEST RECORDS: All records of tests and inspection shall be kept in suitable forms approved by the Bureau. 2.1 Copies of any record and other connected papers that may be required by the Bureau shall be made available at any time on request. 3.0 QUALITY CONTROL: It is recommended that as far as possible, statistical Quality Control (SQC) methods may be used for controlling the quality during production as envisaged in the scheme see IS 397 (Part 1):1972, IS 397 (Part 2):1975 and IS 397 (Part 3):1980. 4.0 In addition efforts shall be made to gradually introduce the Quality Management System as per IS/ISO 9001 as appropriate to the activities of the organization. 5.0 STANDARD MARK: The Standard Mark as given in column (1) of the First Schedule of the license shall be stenciled on each container of Disinfectant Fluids, Phenolic type or printed on the label applied to the container as the case may be, provided always that the material in the container to which this Mark is thus applied conforms to every requirement of the specification. In case of 25 litres tins the Standard Mark may also be incorporated in the lead seal. 6.0 MARKETING: In addition, the following information shall be given on each container or printed on the label applied to it: a) Name of the product; b) Manufacturer’s name, initials or trade mark; c) Class, Grade and type of the material and phenol coefficient (Rideal


Walker or Rideal walker and staphylococcal); d) Batch number/Control Unit; e) Month and year of manufacture; f) Net volume in ml or l; g) Any specific instructions for use; h) A statement that mercury compounds have not been added to the product; i) Date of expiry; j) Any other marking required under the Weights and Measure (Packaged Commodities) Rules and Drugs and Cosmetic Rules, 1956; and k) CM/L---------- 7.0 PACKING: The material shall be packed as per Cl.5 of IS 1061:1997. 8.0 CONTROL UNIT: For the purpose of this scheme, the entire quantity of disinfectant fluids, phenolic type homogenized at a time in one tank shall be considered as a Control Unit. 9.0 LEVELS OF CONTROL: The tests, as indicated in table 1 and at the levels of control specified therein, shall be carried out on the whole production of the factory covered by this Scheme and appropriate records and charts maintained in accordance with Paragraph 2 above. All the production which conform to the Indian Standard and covered by this license shall be marked with the Standard Mark. 9.1 A sample of the material shall be drawn from each C.U. and tested for all the requirements of the specification except for stability on storage. If the sample fails in any of the requirements, the batch shall be rejected. The rejected material could however, be reprocessed and the defects rectified. Such reprocessed material when tested again shall confirm to all the requirements of the specification for the relevant grade before it is used for making. 9.2 The sample of each type shall be kept for stability on storage every month and shall be tested just before the expiry period declared by the manufacturer. If it fails, a thorough check shall be made of the process of manufacture, as also of the raw materials used in the manufacture of the materials. 9.3 Mercury compounds shall be strictly excluded from all grades of disinfectant fluids. 10.0 In respect of all other clauses of the specification and at all stages of production appropriate controls and checks shall be maintained by the factory so as to ensure that the product conforms to the various requirements of the specification.


11. RAW MATERIALS: It is recommended that routine analysis of various raw materials used in the manufacture of disinfectant fluid shall be made on each lot received in the factory and appropriate records to be maintained. 12.0 REJECTION: A separate record shall be maintained giving information relating to the rejection of the production not conforming to the requirements of the specification and the method of its disposal. Such material in no case be stored together with those conforming to the requirements of the specification. 13.0 SAMPLE: The licensee shall supply, free of charge, the samples required in ccordance with the Bureau of Indian Standard (Certification) regulations, 1988 as subsequently amended from his factory or godown. The Bureau shall pay for the samples taken by it from the open market. 14.0 REPLACEMENT: Whenever a complaint is received soon after the goods with Standard Marks have been purchased and used and if there is adequate evidence that the goods have not been misused, defective goods are replaced free of cost by the licensee in case the complaint is proved to be genuine and the warranty period (when applicable) has not expired. The final authority to judge the conformity of the product to the Indian Standard shall be with the Bureau. 14.1 In the event of any damages caused by the goods bearing the standard Mark or claim being filed by the consumers against BIS Standard Mark and not ‘conforming to’ the relevant Indian standard, entire liability arising out of such non-conforming product shall be of licensee and BIS shall not in any way be responsible in such cases. 15.0 STOP MARKING: The marking of the product shall be stopped under intimation to the Bureau if, at any time, there is some difficulty in maintaining the conformity of the product to the specification, or the testing equipment goes out of order. the marking may be resumed as soon as the defects are removed under intimation to BIS. 15.1 The marking of the product shall be stopped immediately if directed to do so by BIS for any reason. The marking may then be resumed only after permission by BIS. The information regarding resumption of markings shall also be sent to the Bureau. 16.0 PRODUCTION DATA: The licensee shall send to the Bureau as per the enclosed Proforma, to be authenticated by a Chartered accountant a statement of quantity produced, marked and exported by them and the trade value thereof at the end of each operative year of the license


IS 1061: 1997 DISINFECTANT FLUIDS, BLACK AND WHITE

TABLE 1 LEVELS OF CONTROL (Clause 9.0 5 of Scheme of Testing and Inspection)

TEST DETAILS LEVELS OF CONTROL

Test Method Clause Requirements

Clause

Reference

No. of Samples

Frequency

Remarks

4.1

Composition and Description

4.1.1 or 4.1.2

IS 1061:1997

One

Each Control Unit.

4.2

Stability after dilution

Annex-A

-do-

One

-do-

4.3

Germicidal Value

Annex-B & C

-do-

One

-do-

4.4

Mercury Compound

Annex-D

-do-

One

Once in a month.

4.5

Stability on storage

4.2,4.3 & 4.5

-do-

One

Once in month

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