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Agile Product Lifecycle Management Getting Started with Agile Management for Pharmaceuticals Release 9.3.3 E39289-01 |
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# 7 Working with RMW Environment

Specifications for the storage environment of a newly created material are of significant importance. These specifications are used to prepare the SARA 311/312 report, where each material's storage condition over a period of time is reviewed and reported. When you create a new material, you need to specify the storage environment, which constitutes of:

- Ambient Conditions - Temperature, pressure, humidity and clean room levels.

- Chemical Abstract Service (CAS) number.

Description of the illustration ch7_01.jpg

## 7.1 Creating a New Environmental Condition

Environment and storage conditions specified at the time of material definition ensure material containers are stored as per conditions specified. You can add new environment conditions as required. RMW records these conditions for verification.

To create new environmental condition:

1. From the Create New menu, select Environmental >Condition.

2. In the General tab, enter the information.

   Significant inputs:

   - Name

   - Clean Room Levels

   - Min. Temperature

   - Max Temperature

   - Min. Pressure

   - Max. Pressure

   - Min. Humidity

   - Max. Humidity

3. Click Finish.

## 7.2 Working with Chemical Abstract Service Record

RMW provides recording and retrieval details of Chemical Abstract Services (CAS) of materials. For details, see Recipe & Material Workspace Material Management Guide.

### 7.2.1 Creating a New CAS Record

The CAS record indicates the constituents of a material and is a part of material definition.

To add a new CAS record:

1. From the Create New menu, select Environmental > CAS.

2. In the General tab, enter the unique Chemical Abstract Service Number of the chemical.

   Significant points to note:

   - CAS Number - Enter a unique number for the chemical.

   - CAS Name - Enter a unique name of the chemical.

   - Mass Balance Required Flag - Select Yes if you require Mass Balance report for this material.

   - SARA 312/EPCRA TPQ - Select Yes if the Inventory quantity limit for the material is set by Superfund Amendments Reauthorization Act, Section 312 regulation.

   EPCRA stands for Emergency Planning and Community Right-to-Know Act.

   - Is Tracked By SARA 302 - Select Yes if the material is in Environmental Protection Agency's Superfund Amendments Reauthorization Act, Section 302.

   - SARA 313 Reportable Flag - Select Yes if the material is listed in Environmental Protection Agency's Superfund Amendments Reauthorization Act, Section 313.

   - OSHA Reportable Flag - Select Yes if the material is listed in Occupational Safety and Health Administration.

   - OSHA TPQ - Enter the inventory quantity limit for the material as set by Occupational Safety and Health Administration and select a unit of measurement.

   - OSHA TPQ Alert% - Specify the percentage of amount in the inventory at which the RMW should send alerts.

   - HAP Flag - Select Yes if the material is a Hazardous Air Pollutant. If you select Yes this CAS ID appears in the Air Emissions report.

   - CERCLA TPQ - Enter the inventory quantity limit for the material that is set by Comprehensive Environmental Response, Compensation, and Liability Act.

   - VOC Flag - Select Yes if the material is a Volatile Organic Compound material.

   - RCRA - Enter Resource Conservation and Recovery Act code.

3. Click Finish to save and exit.

You can also create a new CAS in the Safety & CAS sub-tab, while adding a chemical to the Material library. For more details, see Agile Recipe Management for Pharmaceuticals Material Management Guide.