| Title: Hose Management | |||||
| Guidance Number: 96 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Introduction
What minimum standards should be considered by an API manufacturing site for the storage, handling and cleaning of hoses used during cleaning or production of Intermediates or final Active Pharmaceutical Ingredients (APIs)?
This guidance will only deal with hoses that can be moved and used for multiple purposes rather than flexible lines that are permanently fixed to the equipment (e.g. flanged). A flexible line that is permanently fixed to the equipment should be managed and maintained in accordance with the site maintenance practices.
This document is intended to provide general guidance on:
- Hose Use Procedure
- Considerations When Developing Site Hose Specifications
- Preventive Maintenance
- Visual Inspection (Verification) Prior to Use or Storage
- When and how often should hose inspection be done?
- Labeling and Traceability
- Cleaning of Hoses
- Storage and Handling
- Managing Hose Failure Incidents
This document will assist Site API manufacturing facilities in developing and implementing site-specific hose management practices, if not currently existing, or enhance prevailing hose practices that put emphasis on both Quality and Operational efficiency.
Recommendations & Rationale for Recommendations
Hose Use Procedure:
GMP sites should have procedures defining the use, specification, storage, handling, cleaning and maintenance of hoses used in cleaning and production of intermediates and APIs in accordance with cGMP guidelines. Flexible hoses should be adequately identified, maintained, and cleaned.
Section 5.2 – Q7A, emphasizes written procedures should be established for cleaning equipment and its subsequent release for use in manufacture of intermediates and APIs. In addition, sites should have standardized hose management practices, including management of change, with written procedures that identify factors to be considered and evaluated.
Considerations When Developing Site Hose Specifications:
Each hose assembly should meet or exceed the applicable requirements in functionality, dimension, characteristic or industry standards. A cross-functional evaluation and approval
on hose specifications among site’s responsible personnel (i.e., engineering, quality, production/operations, maintenance, and safety representatives) and collaboration with approved hose vendors/distributors in discussing specific hose needs will help assure new hoses are ordered right the first time.
Incorporating such specifications into the appropriate site’s hose management procedure is suggested. A matrix showing compatibility of hose assemblies & fittings with required applications would be a helpful tool.
Simplify and reduce the number of hose classifications, as much as possible. Where practical, customize hose specifications for a broader range of uses to make it simpler and safer to use the correct hose.
When developing site hose specifications, considerations should be given to the following:
- Dedicated hose vs. Multi-purpose hose – If conditions allow, the preference should be for dedicating hoses to a specific use to prevent risk of cross-contamination. Dedicated or not, hoses should be tracked with unique identification and cleaned appropriately. Cleaning should always be made a requirement even if hoses are dedicated.
- Material of Construction – Hoses and gasket should withstand the rigors of the chemical process. Selection of the chemical hose with the most suitable material of construction in relation to the intended application becomes extremely critical. The hose and gasket should meet the demands of or be compatible with each service function and operating conditions (flow, pressure, temperature, chemical compatibility, and chemical resistance) in order to avoid potential reactions that could affect product quality or jeopardize safety. Hoses should not shed extraneous matter or leach materials into the process.
- Gaskets – Only gaskets that meet or exceed the requirements of the chemical process and hose assembly specifications should be used for chemical transfer hoses. Requiring an inspection and replacement of transfer hose gaskets on a routine basis will help detection of potential gasket failures that might eventually cause unexpected product cross-contamination. Establish an inspection procedure and frequency of replacement for gaskets prior to hose reconnections in order to prevent leaks and spills. Frequency of replacement should be based on the gasket type/material, process service pressure/temperature conditions, cross-contamination issues, safety issues, and plant experiences.
- Length of hose – The hose length is typically restricted by the storage and handling procedure. It should be small enough for use but not so short to prevent excessive hose bends/kinks that can lead to premature mechanical fatigue/failure. It should be long enough for use but not so long to avoid impact on the effectiveness of cleaning. Avoid using multiple hoses, which are connected in series in order to extend hose lengths. This will reduce the risk of mechanical damage/failure of the inter-hose connections and leaks and spills at the connections.
The National Association of Hose and Accessories Distributors (NAHAD) published a simple-to-use guide that assist in determining the correct hose, coupling and attachment method that will satisfy the needs of particular applications. NAHAD uses the acronym “STAMPED” to identify the seven major information areas – Size, Temperature, Application, Material, Pressure, Ends, and Delivery – required for specification of a suitable hose assembly.
Preventive Maintenance:
Detection of early warning signs of hose deterioration or loss of performance before conditions leading to malfunction or failure should be the primary goal of a hose preventive maintenance program. A good hose preventive maintenance program should include the following:
- An SOP that sets processing requirements to ensure hose integrity;
- A program that provides documented tracking of the age and conditions throughout the life cycle of the hose;
- A plan that defines maintenance requirements based on engineering and safety best practices;
- Standardization of hoses and end fitting types when at all possible Specifically, a hose preventive maintenance program is expected to set minimum requirements calling for tests including.
Visual inspection – each hose assembly is inspected for damage to the cover or body of the hose. Kinks, cuts, abrasions, and crushed areas are reasons for failures. An internal visual inspection of the end fitting will reveal if tube failure has occurred. A damaged hose body makes the hose susceptible to leaks or ruptures.
Continuity test – performing this test on each hose assembly will eliminate ungrounded hoses.
Hydrostatic test – performing this test will help remove leaking hose assemblies from service.
If failure in one or all of the above tests is experienced, prompt replacement or repair of hose is recommended. There should be a procedure that ensures consistent hose preventive maintenance, inspection and replacement practices. A reliable hose preventive maintenance program will promote a longer hose life cycle and establish hose replacement frequency in the most economical way.
Visual Inspection (Verification) Prior to Use or Storage:
Early detection of a flawed hose prior to use can ultimately avoid implicating lots of material in the event of a hose failure. Performing a verification of hose integrity and configuration of connections just prior to use and storage is certainly an added value, as it will prevent costly material spills, cleanup, downtime and potential injury.
Visually inspect all chemical hoses prior to use or storage by examining the interior of the hose ends, especially near the coupling for possible damage to the Teflon inner lining. Check the gasket area and the hose exterior for cracks, cuts, kinks, flattening, broken kamlock ears, etc. If any damage is detected, initiate the necessary repair or replacement.
When and how often should hose inspection be done?
Inspection requirements will vary with each application type. The following factors should be considered:
- Critical nature of application
- Operating temperatures
- Operating pressures
- Other environmental factors
Labeling and Traceability:
Use and status of cleaning of hoses need to be traceable. Hence, only a hose that is properly identified should be put into service. A unique identifier should be assigned to each hose assembly. A unique ID can be engraved into the collar of the hose and this is the preferred method for permanent identification. The use of label or tag made of durable material that will contain essential hose information and resist fading can also be considered. Essential hose label information could be a combination of the following: serial/tag number, vendor name, manufactured date, hose materials, key hose design specs, unit/location assignment, last inspection/test dates, and first use date, etc.
A written procedure for tracking hose maintenance including the use of tracking software, logbook or alternatives is recommended. This will assure monitoring on the proper maintenance, inspection, and testing throughout the service life of a hose.
From a manufacturing or processing standpoint, documentation of the hose identification into a production record, cleaning record or register, or equipment use log should be considered to allow ease in tracking the use of a hose in the event of product failure or deviation and to facilitate review in determining proper hose use.
Cleaning of Hoses:
Typically, a hose used in API or Intermediate production is cleaned as part of the equipment train (in-line cleaning) to which it is attached for manufacturing. Occasionally, off-line cleaning (individual hose cleaning) is performed on specific instances.
When a hose is a product-contact equipment, it should be cleaned in accordance with the requirements of established site quality procedures such as “Equipment Cleaning For APIs” and “Equipment Cleaning Validation for APIs”.
Whether the hoses are cleaned as part of the equipment train or separately, the same criteria apply, as follows:
- Hose cleaning and verification activities should be entered and maintained in applicable records.
- Changeover cleaning verification should include rinsate sampling and testing.
Solvents used for final rinsing, including water and recovered solvents, should be of the same quality, or higher quality, as the solvents used for subsequent processing.
New hoses and those returned from maintenance should be given special considerations for cleaning purposes. Flushing with appropriate solvent or water to remove undesirable debris is usually sufficient. Analytical verification of a rinsate sample, at this point, is not necessary because the routine verification tests typically do not detect contaminants, such as environmental debris, that result from maintenance. For safety reasons a hose should be cleaned by trained operations personnel before delivery and acceptance for maintenance work.
For solvent hoses that are used for multiple solvents, the need for cleaning verification via analytical testing will depend on the next use of the hose. That is, if the next hose use involves a different solvent, verification to show the absence of the previous solvent should be considered through scientific rationale or analytical testing.
Storage and Handling:
After hose cleaning is performed the hose should be handled and stored according to written procedure that may include the following –
- Dry with filtered air or Nitrogen and then
- Cap or cover ends Or, alternatively,
- Hang
- Allow to drain/dry
- Cap or cover ends
- Label the hose as clean ready to use
There should be an established procedure for the proper storage conditions for hoses. For easy handling, consider using hose racks. The hose should be stored uncoiled with the ends oriented downwards but not touching the floor in a designated storage area. To prevent foreign matter contamination and diminish the potential of undesirable microbial contaminants, covering hose ends with suitable material after the hose is dried is recommended. While in storage, the hose or the area where it is kept should display the hose’s cleaning status via a label or tag to allow verification when it is returned to service.
Managing Hose Failure Incidents:
The chemical hose is the weakest link in the chemical transfer system. The tracking of failure incidents as a component of a hose management program will serve an added assurance that an effective system exists for maintaining and monitoring hose condition and performance throughout its life cycle.
Hose failure incidents attributed to damaged physical conditions including failed cleaning results should be treated like any other incident and should be captured in the site deviation system, investigated, and documented in accordance with site SOPs. The investigation should consider:
- Scope, i.e., how many lots were produced using the failed/damaged hose
- Potential for physical and chemical contamination of the product from the hose Failure.