3. Applicable Documents
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This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Title: Basis of Design, Valencia – Building 28515 Document D000002491 Number:
Rev Description ECO # Date Originator 07/16/1 Joseph Miranda / Validation A New Facility Move Document XXXX 0 Consultant
Author/Project Manager:
JOSEPH MIRANDA
Director of Manufacturing:
BILLY MORRISON
Manager, Quality Assurance: BERNICE ROMO
Director, Product Engineering:
ARTHUR RASCON
Director, Reliability:
TOM SANTOGROSSI
Director, Facilities:
ADVANCED BIONICS Rev: PA Page 1 of 8 9196200 H This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Title: Basis of Design, Valencia – Building 28515 Document D000002491 Number:
KEN HUGUENIN
ADVANCED BIONICS Rev: PA Page 2 of 8 9196200 H This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Title: Basis of Design, Valencia – Building 28515 Document D000002491 Number:
1. PURPOSE The purpose of this document is to provide the guidelines and requirements for the qualification of the Finished Goods Warehouse located at 26081 Avenue Hall, Valencia Ca 91355 servicing Advanced Bionics, LLC at the Valencia Facility address known as 28515 Westinghouse Place, Valencia, CA 91355. This document establishes the minimum specification requirements for the Finished Goods Warehouse.
2. SCOPE The scope of this document encompasses the specification requirements for the qualification of Advanced Bionics, LLC at Valencia, CA facility. These requirements shall be used in the design and ultimately the construction of the Finished Goods Warehouse.
3. APPLICABLE DOCUMENTS Reference Document Reference Title 21 CFR Part 820 Quality System Regulations ANSI/ESD S20.20 1999 Protection of Electrical and Electronic Parts, Assemblies and Equipment OP 4.1.1 Manufacturing Environmental Requirements OP 3.7.5 Controlled Environments-Classification and Monitoring for Compliance OP 4.1.3 Manufacturing Equipment and Facilities Maintenance
4. GENERAL REQUIREMENTS The utility requirements shall be gathered from all areas and be approved by the respective functional representative(s). Additionally, these requirements shall conform to all ISO, ANSI and FDA regulations for Medical Devices. They shall be described discreetly per area; cumulative totals and recommendations for overall facility utility requirements and pipe sizing shall be determined by the architect/engineer signed into the agreement for construction of the facility. Any changes to the requirements shall be reviewed and approved by the functional representative(s) from Quality Assurance, Manufacturing Engineering, Facilities, and Validation as applicable. Any updates to this document shall be revision-controlled.
5. DETAILED REQUIREMENTS Advanced Bionics Finished Goods warehouse, which will be climate and access controlled, will be used for the inventory storage, order fulfillment, packaging, shipping and fulfillment of associated requirements to distribute finished product which that have been approved for commercial sale and distribution. ADVANCED BIONICS Rev: PA Page 3 of 8 9196200 H This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Title: Basis of Design, Valencia – Building 28515 Document D000002491 Number:
This area will also store those accessories associated with finished configurations needed to complete various sales order kit configurations. Packaging materials such as boxes and pack cushioning that is used to configure and ship these products to external customers will also be stored in this area.
The utilities environmental requirements for manufacturing are within the range specified in this Basis of Design; these requirements were based on the Sylmar environmental requirements. The updated requirements are included in OP 4.1.1 and OP 3.7.5.
6. SPACE ALLOCATION – BUILDING 26081 UNIT D In reference to the general floor plan, refer to current construction drawings located in the facilities department. Drawings shall outline the following activities:
ADVANCED BIONICS Rev: PA Page 4 of 8 9196200 H This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Title: Basis of Design, Valencia – Building 28515 Document D000002491 Number:
Area Description
Products ready for distribution will be stored in this area under the required storage conditions. Activities in this area will be: Inventory storage and management in pallet and flow rack environment Inventory movement using battery operated forklifts, pallet jacks, non powered carts, and conveyer Finished Goods Order picking using RF scanning Order packaging with standard of the shelf non hazardous materials -Order shipping using standard carrier services such as FedEx and UPS -Perform standard PC based inventory shipping and receiving functions
This area is considered to be a low volume, low traffic, and low risk warehouse environment.
7. DESIGN AND CONSTRUCTION The design and construction shall ensure cGMP compliance with 21 CFR Part 820, Quality System Regulation (QSR).
ROOM REQUIREMENTS
ADVANCED BIONICS Rev: PA Page 5 of 8 9196200 H This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Title: Basis of Design, Valencia – Building 28515 Document D000002491 Number:
7.1. FINISHED WAREHOUSE COMPOSITION
Description Specification Room shell construction Non-shedding and washable material Ceiling Tiles Non-shedding, washable and sealable material
7.2. ENVIRONMENT
Environment Requirement Specification Finished Temperature 60°F - 80°F 7.2.1. Goods
7.3. LIGHTING The lighting system provides ≥ 80 foot candles at bench top work surface areas. The lighting system consists of a combination commercial-grade ceiling mounted fluorescent light fixtures and work station lighting.
Requirement Specification Manufacturing Area @ work surface > 80 Foot Candle > 20 Foot Candle in general warehouse space FG Warehouse lighting > 60 Foot Candle at work surfaces* * 1 outlet at every workbench
ADVANCED BIONICS Rev: PA Page 6 of 8 9196200 H This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Title: Basis of Design, Valencia – Building 28515 Document D000002491 Number:
7.4. FLOORING
ADVANCED BIONICS Rev: PA Page 7 of 8 9196200 H This document is CONFIDENTIAL and contains designs and/or other information that are the property of Advanced Bionics, LLC. This document and the designs and/or other information contained therein, may not, in whole or part, be duplicated or disclosed or used for the manufacture of any part(s) disclosed herein, or for any other purpose, without the prior written permission of Advanced Bionics, LLC. Title: Basis of Design, Valencia – Building 28515 Document D000002491 Number:
7.5. FLOORING The flooring should be a hard surface that is easily cleanable. Palletized goods storage areas must have a “clear zone” between the walls and the pallets to facilitate rodent control and general cleaning, and for inspection access.
Requirement Specification 7.5.1. Seal concrete Fill all cracks w/ epoxy filler
ADVANCED BIONICS Rev: PA Page 8 of 8 9196200 H