SOW-Dishwasher.docx

STATEMENT OF WORK

Project Title: Laboratory Glassware Washer

Department: NIH Clinical Center, Investigational Drug management and Research Section, Pharmacy Department

1. Background Information

The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC Pharmacy department provides a range of pharmaceutical care services to inpatients and outpatients enrolled in clinical trials. The Pharmacy Department’s Investigational Drug Management and Research Section (IDMRS) prepares customized investigational drug products, and assists investigators in filing Investigational New Drug (IND) applications with the FDA.

a) IDMRS supplies for the Clinical Center, the preparation, manufacturing through outsourcing and testing of investigational drug products not available from other sources. The products prepared in IDMRS are used in Phase I and Phase II clinical trials. These products must meet FDA current Good Manufacturing Practice (cGMP) requirements for pharmaceutical manufacturing and for the testing of these products to ensure patient safety.

b) Current Good Manufacturing Practice (cGMP)

Section 501 [21 U.S.C. § 351] (a) (2) (B) of the Federal Food, Drug, and Cosmetic Act requires the methods, facilities, and controls used for the manufacturing, processing, packaging, and holding of drug products to conform to current Good Manufacturing Practices (cGMPs) in order to ensure the safety, identity, strength, quality, and purity of the drugs produced. The federal Food and Drug Administration (FDA) has general rulemaking authority to issue regulations for the efficient enforcement of the act. The FDA regulates pharmaceutical manufacturing through the Code of Federal Regulations (CFR), specifically the following sections:

The FDA further discusses procedures and practices to meet cGMPs through various venues, including the publication of Guidance for Industry documents, several of which are applicable to the operations that take place in PDS. Two very relevant and important guidance documents include cGMP for Phase I Investigational Drugs and Sterile Drug Products Produced by Aseptic Processing – cGMPs.

c) Regulatory Requirements for IDMRS Operations

IDMRS engages in the manufacture (through outsourcing), packaging, distribution, and holding of drugs and drug products for Phase I and Phase II clinical trials, and contributes to the submission of IND applications to the FDA.

The FDA makes clear that an investigational drug for use in a Phase 1 study is subject to the statutory requirements set forth at 21 U.S.C. 351(a)(2)(B). Drugs for Phase 2 or Phase 3 study must comply with all regulations set forth by 21 CFR 210-211.

As such, IDMRS is subject to the regulatory authority of the FDA and must operate under cGMP conditions. Additionally, vendors providing equipment or services to IDMRS must know, understand, and apply cGMP conditions since IDMRS is reliant upon the manufacturer or service provider to meet many of the required quality aspects of the goods or services provided.

2. Justification of Laboratory Glassware Washer in IDMRS/Analytical Unit (AU) Both pharmaceutical and medical device production and/or testing facilities require chemically and biologically clean equipment for QA analysis. Also having wide selection of washing and loading accessories is helpful for optimal workflow and productivity.

AU is charged with a series of responsibilities including following product stability over the time frame that clinical trials last. To be cGMP compliant, the tests should be performed using clean glassware to avoid any cross contamination between tests.

3. Laboratory Glassware Washer Specifications

General Description: PG 8583 CD Laboratory Glassware Washer -35.5" wide unit with detergent storage cabinet and integrated HEPA-filtered forced air drying.

Includes steam condenser, conductivity meter, stainless steel interior and exterior, two internal pumps for liquid detergent and neutralizer dispensing. A third internal pump for liquid detergent dispensing can be added by Miele Service.

Standard Electric: 3 AC 208V 60 Hz, 3-pole 20 A, 6.2 kW, NEMA L15-20

Water Connections: 1 Hot | 2 Cold | 1 DI Water

Liquid Dispensing: 2 internal pumps (3rd pump optional)

Dimensions:

Accessories:

A 100 upper basket for modules A 302 module for laboratory glassware 4x8 (x2) A 150 lower basket for modules A 301 module for laboratory glassware 3x6 (x2) A 101 upper basket A 303 module for pipettes Intensive alkaline cleaning agent, free of surfactants Acid neutralizer, based on organic acids

Installation: Under counter installation

Validation Documents: Complete IQ/OQ documentation package for validation of PG 8583CD Laboratory Glassware Washer. Document is over 50 pages in length and provides a step-by-step guide for validating proper installation, alarm conditions, operational messages and wash program parameters. Provides easy guideline for end-user or 3rd party to validate the washing system. This document is provided as a hard copy in the binder.

Validation Execution: On-site execution of validation of the PG 8583CD. Validation procedure is expected to take approximately 2 days and will require approvals and coordination with customer. Price includes labor, travel, and expenses for completed validation. Package includes full execution of IQ and OQ. 21 days advance notice required. Validation Documents must be purchased separately.

Warranty: 5 Year Limited warranty for undercounter machines. This Limited Warranty commences after Miele’s original manufacturer’s first year warranty expires and stays in effect for 4 years. The warranty covers wash chamber construction, the control electronic/microprocessor, circulation pumps and drain pumps. It also includes free call center and application support for the life of the product and is based on the ongoing use of neodisher detergents.