Upon Installation

Following successful completion of the pre-installation process, it is time for the system to be installed and to implement the core of the validation protocol—the IQ/OQ/PQ. Based on the overall timeline, these procedures have been grouped into two task groups upon installation and pre-installation. Focusing on the upon installation tasks, these include both the IQ and OQ protocol, implemented in respective order. They can be generally defined as follows  

Installation Qualification—The IQ is the protocol that verifies that the installation of the system has followed the guidelines established within the validation plan and is in accordance with the vendor s installation requirements. 

Operational Qualification—The OQ is the protocol that verifies that the operation of the system meets the written and pre-approved performance and functional specifications established by the vendor within its required operating range. 

For the hardware installation and IQ implementation on a full HPLC system, one should expect to allocate about 2 days. For the OQ, it is recommended that about 1 day be allocated. 

Note As is often the case, the HPLC system will be under computer control, which is likely to be part of a data-handling system. Since the data generated from the OQ hardware tests typically require chromatographic data handling, the data-handling software should be validated beforehand. The data-handlingfLC control software installation and IQ/OQ implementation, which are not addressed in this chapter, may take a considerable amount of time. This is often the case since this process typically involves an initial client/server implementation. 

---

The validation procedure can be subdivided, as per timeline, into three discrete task groups pre-installation, upon installation and postinstallation. The subsequent sections in this chapter will focus on each of these, defining the terms and providing a chronological progression of... 

Each pump should be subjected to a full acceptance test upon installation, as specified in NFPA 20. The manufacturer s shop test pump curves should be available for comparison during the acceptance test. 

Levobetaxolol - Ophthalmic Transient ocular discomfort upon installation (11%). 

Assume that a very successful company produces 1000 transdermals per day. Due to market demand, its manufacturing department is instrumental in purchasing a new piece of equipment that will reportedly yield 1500 transdermal systems per day. Manufacturing requests facilities to remove the old piece of equipment and install this new piece of equipment. Upon installation, manufacturing attempts to use this new piece of equipment and finds that it won t run continuously—it only runs for 1 hr and then shuts down. In addition, manufacturing has also found that the equipment is only capable of running at 75% of its reported production rate. 

Check surface preparation techniques Use robust metal primer Avoid dissimilar metal contacts upon installation of finished bonded parts Avoid dissimilar metals in abrasion cleaning operation, i.e., steel grit with aluminum... 

Modules are connected to each other using an interconnector adaptor, as shown in Figure 4.19. The interconnector has O-rings at ether end to ensure a tight seal with the module ATDs. These O-rings can roll upon installation into membrane modules, thereby... 

A bolt from an aircraft flap control unit fractured in the threaded region of the shank near the shoulder with the head upon installation after a major service. The bolt was made from cadmium-plated high-strength steel. The bolt conformed to the specifications and had ultimate tensile strength of 4400 MPa. 

Surveys. Radiation surveys of all analytical x-ray systems sufficient to show compliance with the radiation levels established in the previous item must be performed (1) upon installation of the equipment and at least every twelve months thereafter (2) following any change in the number, type, or arrangement of components in the system (3) following any maintenance requiring the disassembly or removal of a system component. 

Upon installation, HEPA filters shall be integrity tested by a suitable method, e.g., cold DOP test... 

To ensure practically no leakage, a leakage test is commonly conducted upon installation. In this test, the weep holes are plugged and the trays are filled with water to the top of the weir. The rate of fall of water level is then measvu ed. It has been recommended that this rate should not exceed 1 in per 20 minutes (48, 86, 257, 371, 409). If the leakage is not critical, a more liberal tolerance can be adopted (48). This test is not always conclusive, because a tray that leaks badly under test conditions may perform satisfactorily at the design temperature and vice versa. 

Data Analysis A calibration curve of the fluorescence detector should be obtained upon installation and once every month using a concentration range of dGSH in water 5 mM dithiothreitol in methanol (1 2). QC standards (preferable with a concentration of 1 pM) should be included in each batch of analysis to ensure accuracy of calibration. The fluorescence response factor is usually very consistent. Thus, daily calibration is not recommended. 

The surveillance programme should be developed by the operating organization sufficiently early to permit it to be properly implemented as and when plant items become operational in the commissioning phase or, where appropriate, upon installation. Implementation should be scheduled such that the safety of the plant does not depend on untested or unmonitored SSCs. 

O-rings can roll upon installation into membrane modules, thereby... 

The simplex SC connector and adapter are keyed to ensure the same orientation of the connector upon mating. Upon installation of the duplex yoke, to make two simplex SC connectors into a duplex 568SC, the keying establishes the orientation of one fiber to the other (polarity) because the 568SC connector can only... 

Load actual pressure at a sealing face in the case of a shaft seal, the sum of the elastomeric lip s inherent beam force, the hoop force (as a result of lip stretch upon installation) and the garter spring tension, all of which contribute to shaft loading at the contact point. 

Upon installation and prior to routine use Post major repair... 

---