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LAB-115 Use and Control of laboratory Chemical Materials

DepartmentLaboratoryDocument noLAB-115
TitleUse and Control of laboratory Chemical Materials
Prepared by: Date: Supersedes: 
Checked by: Date: Date Issued: 
Approved by: Date: Review Date:

1.0 DOCUMENT OWNER

Laboratory/Quality Manager

2.0 PURPOSE

This document describes the requirements for receipt, labelling, handling, storage, standardization and review of laboratory chemical materials in the Quality Control (QC) Laboratory.

3.0 SCOPE

This procedure applies to laboratory chemical materials, including but not limited to, chemical substances, chemical solutions, chemical reagents, cleaning solutions and chemical waste both prepared within the QC Laboratory and obtained commercially.

This procedure does not apply to Production Samples or Reference Standards.

For handling and management of Production Samples, refer to SOP LAB-100 Laboratory In Process and Finished Product Quality Control

For handling and management of Reference Standards, refer to SOP LAB-020 Management of Reference Substances.

4.0 RESPONSIBILITY \ BUSINESS RULES

The Laboratory Manager and Team Leaders are responsible for ensuring that all responsible personnel who work within the QC Laboratory follow this procedure.

It is the responsibility of all Analysts and Laboratory Attendants who work within the QC Laboratory to follow this procedure.

5.0 PROCEDURE

5.1 Receipt of Laboratory Chemical Materials Obtained Commercially

This section does not apply to laboratory detergents or miscellaneous general duty materials.  Refer to Section 5.1.3 of SOP LAB-060 Raw Materials-Laboratory Testing and Documentation – for details on the receipt of laboratory detergents and miscellaneous general duty materials.

The laboratory designee receiving chemical materials obtained commercially performs the following steps:

5.1.1 If the laboratory designee receiving the material is unsure of the safety, handling or storage requirements for the material, obtain a copy of the corresponding Material Safety Data Sheets (MSDS) from EH&S and review the document.

The laboratory MSDS folders are located in the document compactor.

NOTE: If the MSDS cannot be found in the laboratory MSDS folders, or through the above link, contact the EHS group for assistance.

5.1.2 Adhere a Laboratory Receipt label to the material container.

5.1.3 The following information should be included on the Laboratory Receipt label:

a. Receipt date

b. Received by (initials)

c. Quantity received

d. Expiry date (as specified in Section 5.4)

5.1.4 When bulk organic solvents arrive on site they are stored, in bulk, in the outside dangerous goods store.  A Laboratory Receipt label is to be attached to each container.  Where external packaging exists a Laboratory Receipt label is to be attached to the outside of the box.

5.1.5 When the bulk container is transferred to the laboratory, the bottles are to be removed from the packaging and a Laboratory Receipt label is to be attached to each bottle, with the received date reflecting the Laboratory Receipt label that is on the outside of the box.  Table 1: shows which bulk chemicals are stored in the dangerous goods store.

ChemicalStorage
MethanolBottles in external packaging
EthanolDrum
AcetonitrileBottles in external packaging
DichloromethaneDrum

Table 1:  Chemicals Stored in External Dangerous Goods Store

Note: Section 5.3 – Labelling of Laboratory Chemical Materials – details the labelling requirements for laboratory chemical materials.

5.1.6 Store the material as per the information detailed in the MSDS and according to the procedure in Section 5.6 – Storage of Laboratory Materials.

5.1.7 When the container is opened for the first time, complete the Laboratory Receipt label by recording the date opened and signing the label in the corresponding sections.

5.2 Preparation of Laboratory Reagents

The following steps are performed when preparing laboratory reagents:

5.2.1 Determine which material(s) will be used in the preparation of the reagent.  If the analyst preparing the reagent is unsure of either the health risks or appropriate Personal Protective Equipment (PPE) for the material(s), obtain and review the corresponding MSDS(s).  Ensure that the appropriate PPE is worn before commencing preparation.

5.2.2 Prepare the solution following the approved procedure.  Record the details for the preparation of the reagent in the appropriate workbook / logbook:

Note: Documentation requirements should refer to LAB-025 Laboratory Workbooks.

Laboratory Workbook

Used for reagents to be discarded immediately after use.

Volumetric Solution Logbook

Used for all volumetric solutions.

Lab Solution Logbook

Used for solutions (excluding volumetric solutions) that can be assigned an expiry date and reused.

When recording the details for the preparation of a reagent, the following information should be recorded for each material used in the preparation.

a. Material Name / Identity

b. Material Supplier

c. Material Batch /LotNumber

d. Expiry Date of the material used

e. Weight / Volume

Dilution

NOTE: Where a material is a reagent previously prepared in the laboratory, record “Laboratory Reagent” as the Material Supplier and the corresponding Solution Number (as stated on the label) as the Material Batch / Lot Number, e.g.: 0.05M NaOH; Laboratory Reagent; VS 06/027; Exp 23/11/06; 1.5672 g -> 200 mL with RO water.

5.2.3 For a volumetric solution, standardise the solution as per the approved procedure before use.

5.2.4 Label the reagent container according to the requirements in Section 5.3 – Labelling of Laboratory Chemical Materials – and ensure that all relevant sections of the label are completed.

5.2.5 The Lab Solution Logbook should be checked by a second analyst prior to use.

5.2.6 When using a previously prepared reagent, record the workbook / logbook reference number stated on the label in the relevant workbook.

5.3 Labelling of Laboratory Chemical Materials

5.3.1 All labels must be legible and easily read.

5.3.2 The labelling requirements for laboratory chemical materials are detailed in the following table.

NOTE: Electronic copies of labels are kept in shared drive.

Material CategoryLabelling Requirements
Laboratory
Materials Obtained
Commercially
• Receipt date
• Received by (initials)
• Lot identification (e.g. Container I of 4, where more than one container has been received in a delivery)
• Date opened
• Opened by (initials)
• Expiry date
Volumetric Solutions Solution name
• 
Volumetric Solutions Logbook or Laboratory Workbook reference
• Concentration (normality, molarity)
• Conversion factor
• Composition (list all other ingredients including concentrations, e.g. solvents other than purified water)
• Prepared by (initials)
• Preparation date
• Storage conditions, if other than ambient
• Expiry date
• Hazard, risk and safety information (where relevant)
Laboratory
Solutions
• Solution name
• Laboratory Solutions Logbook or Laboratory Workbook reference
• Concentration if applicable (normality. molarity, v/v etc)
• Composition (list all other ingredients including concentrations. e.g. solvents other than purified water)
• Prepared by (initials)
• Preparation date
• Storage conditions, if other than ambient
• Expiry date
• Hazard, risk and safety information (where relevant)
HPLC Mobile Phase• Assay name (e.g. Paracetamol)
• Laboratory Workbook reference
• Composition (List all ingredients including concentrations)
• Prepared by (initials)
• Preparation date
• Storage conditions, if other than ambient
• Expiry date
• Hazard, risk and safety information (where relevant)
HPLC Wash Rinse Solutions• Solution name (e.g. Injector Rinse)
• Laboratory Workbook reference
• Composition (list all ingredients including concentrations)
• Prepared by (initials)
• Preparation date
• Storage conditions, if other than ambient
• Expiry date
• Hazard, risk and safety inform ation (where relevant)
Chemical Materials Transferred to a secondary container

Note: These requirements only apply when transferring material from containers obtained commercially.

 • Material name / identity
Chemical Materials
• Material supplier
• Material batch / lot number
• Transferred by
• Transfer date
• Storage conditions, if other than ambient
• Expiry date
• Hazard, risk and safety information (where relevant)

General Cleaning Solutions (i.e. other than HPLC wash / rinse solutions)• Solution name
• Composition (list all ingredients including concentrations)
• Prepared by (initials)
• Preparation date
• Storage conditions, if other than ambient
• Expiry date
• Hazard, risk and safety information (where relevant)
Waste Materials

Note: When handling laboratory LAB-040 Laboratory Waste Management.

Note: All original labels must he removed before affixing new labels to a waste container.

• Waste Type (e.g. Organic Waste, Acetonitrile Waste)
• Hazard, risk and safety information (where relevant)
• Dangerous Goods Classification label (where applicable)

Reference Standard Solutions• Solution name
• Laboratory Solutions Logbook or Laboratory Workbook reference
• Concentration if applicable (normality. molarity. %v/v etc.)
• Composition (list all other ingredients including concentrations. e.g. solvents other than purified water)
• Prepared by (initials)
• Preparation date
• Storage conditions, if other than ambient
• Expiry date
• Hazard, risk and safety information (where relevant)

 

5.4 Expiry Dates for Laboratory Materials

5.4.1 Where specific shelf life data is detailed in an approved test method, this data will be used to assign the expiry date of the material.

5.4.2 Where a material has been obtained commercially, the expiry date assigned by the manufacturer will be used.

5.4.3 In all other cases, the following table will be used to assign expiry dates to materials.  Where a material cannot be assigned to one of the categories detailed below, the material should be discarded immediately after use.

Material CategoryExampleExpiry Date
Laboratory
Materials Obtained
Commercially
• Solid Reagents
• Liquid Reagents
• Non-Peroxide
Forming Solvents

It no expiry date is supplied by the manufacturer, the expiry date will be from the date of receipt.

5 years for solid chemicals.
3 years for liquid chemicals.

In all cases, if obvious degradation has occurred, the material should be discarded immediately.

Peroxide forming Solvents such as:
• Decahydronaphthalene (Decalin)
• Diethyl Ether
• Isopropyl Ether
• Divinyl Acetylene
• Vinylidene Chloride
• Ethylene GlycoL
• Tetrahydronapthalene
• Cyclohexene
• 1-Pentene
• 1-Octene 

Certain chemicals can turn into dangerous shock sensitive organic peroxides with prolonged storage.

Such chemicals have a shelf life of 12 months from the date of receipt (Unless test show that the
peroxide values are less than 80 ppm).

The peroxide content of peroxide forming solvents should always be checked before use. The peroxide content can be determined by using peroxide test strips. Any solvents found to have peroxide values greater than 80 ppm should be disposed of immediately.

100% Milli-Q water 1OO% Milli-Q water has an expiry date 24 hours
General Test Reagents• Dilute acids and dilute bases
• Bench reagents
• Indicator solutions
• Colourimetric solutions

For dilute acids and bases < 0.1 M concentration, the expiry date is 1 month from the date of preparation.

For all other general test reagents, the expiry date is 6 months from the date of preparation.

For buffered test solutions, the pH should be checked and recorded in the corresponding
laboratory workbook whenever the solution is used for a new experiment.

For Pharmacopoeia test reagents, ensure that the specific Pharmacopoeia requirements for the test reagent are met.

HPLC Mobile Phase and
TLC Mobile Phase
and
Dissolution Media
 

The expiry date for Mobile Phase and Dissolution Media is 7 days from the date of preparation.

For HPLC mobile Phase, degassing by vacuum filtration is required before each run.

HPLC Wash / Rinse Solutions• 10% Isopropanol SolutionH PLC seal and injector wash / rinse solutions have an expiry date of 3 months from the date of preparation.
Organic Cleaning Solutions• Acetone
• Ethanol
• Methanol
• 70% Ethanol

All organic solvents have an expiry date of 6 months from the date of dispensing unless the expiry date of the source material falls first.

Where the expiry date of the source material falls first, this date assigned as the expiry date. 70% Ethanol has an expiry date of 3 months us from the date of preparation.

Reference Standard
Solutions
 

Where there is no guidance given in the corresponding test method for the reference standard solution, the solution will have an expiry date of 24 hours from the date of preparation (a

HPLC run must be initiated within 24 hours of the preparation of the reference standard solution in the sample set).

5.5 Handling of Laboratory Chemical Materials

5.5.1 Appropriate Personal Protective Equipment (PPE) will be worn when handling laboratory chemical materials.  Refer to the relevant MSDS(s) to determine the health risks and appropriate PPE.

5.5.2 Stoppers and caps will be placed onto bottles and containers immediately after use to ensure safe handling and to avoid contamination.

5.5.3 All laboratory chemical materials will be checked for expiry before use and during the weekly laboratory housekeeping.

5.5.4 After use, all bottles and containers will be wiped on the outside to remove any reagent which may have spilled onto the outside.

5.5.5 After use, all bottles and containers will be returned to the appropriate storage location as specified in Section 5.6.

5.5.6 Spillages of laboratory chemical materials will be cleaned immediately as per SOP LAB-110 Safety Procedure in Laboratory.

5.6 Storage of Laboratory Chemical Materials

All laboratory chemical materials within the QC Laboratory at are to be stored according to the storage conditions stated on the label and the MSDS.  Incompatible chemicals should not be stored together unless segregated.

–          All volumetric solutions and unstable liquid reagents will be stored in an appropriate bottle or container with a screw top cap.

–          All Sodium Hydroxide and Potassium Hydroxide solutions should be stored in plastic bottles or containers.

–          All light sensitive solutions should be stored in amber bottles or containers.

–          All temperature sensitive solutions should be stored in the 4 ºC cool room.

–          All flammable liquids are to be stored in the Flammable Liquids safety cabinets.

–          All acids are to be stored in the Acids safety cabinets.

–          All bases are to be stored in the Bases safety cabinets.

–          All toxic materials / poisons are to be stored in the Poisons cupboard.

–          All other solid and liquid materials are to be stored in the reagent cabinet, ensuring that incompatible chemicals are segregated.

Note: Where a material falls under more than one Dangerous Goods Class, it must be stored according to the primary class.

5.7 Disposal of Laboratory Chemical Materials

For disposal of laboratory chemical materials please refer to SOP LAB-040 Laboratory Waste Management.

6.0 DEFINITIONS / ACRONYMS

None

7.0 REFERENCES

LAB-020 Management of Reference Substances
LAB-025 Laboratory Workbooks
LAB-040 Laboratory Waste Management
LAB-060 Raw Materials-Laboratory Testing and Documentation
LAB-100 Laboratory In Process and Finished Product Quality Control
LAB-110 Safety Procedure in Laboratory.

8.0 SUMMARY OF CHANGES

Version #Revision History
Lab-115New