Text For Citation: 02 Item/Group: 001 Hazard: EXPLOSION

Section 5(a)(1) of the Occupational Safety and Health Act of 1970: The employer did not furnish employment and a place of employment which were free from recognized hazards that were causing or likely to cause death or serious physical harm to employees in that employees were exposed to an explosion hazard resulting from the sudden rapid release of energy (pressure) from autoclave #2 located in Bulding 62, LVV department: The following conditions/practices contributed to the existance of this hazard: a) Run sheets which indicated deviations from normal process parameters were not reported and investigated to determine the cause and effect of these variations or cycle faults, on or about February 28, 1992. b) The system software designed to abort the cycle when specific abnormal condition were detected was never field tested, subsequent to installation, on or about April 9, 1992. c) A preventative maintenance program was not established to periodic tests and inspections of critical equipment, including interlocks, indicator lights, pressure and tempera- ture sensors, to reduce the possibility of failure, such equipment, on or about February 28, 1992. d) A preventative maintenance list was not established to schedule periodic tests and inspections of safety relief valves on the sterilizers which could lead to failure of the overpressure protection for the sterilizers, on or about February 29, 1992. e) The locking pin installed by the manufacturer on Sterilizer #2, was replaced with a pin which was smaller in diameter, observed on or about April 8, 1992. f) The datacon printout (run sheets) did not produce a reliable, useable record of cycle conditions, on or about February 28, 1992. g) Run sheets were not reviewed daily by supervisors and the mechanical coordinator to assure paper operation of the sterilizers, on or about February 28, 1992. h) An effective pressure vessel maintenance program was not implemented and managed on or about February 18, 1992. i) Supervisor and operator training did not include the recognition of hazards abnormal sterilizer operation, actions and precautions to be taken and any actions to be avoided in such situation, on or about January 30, 1992. j) Standard Operating Procedure (SOP 222-504) did not accurately reflect employees job requirements nor did it address contingency actions in the event of abnormal condition, on or about March 11, 1992. k) Adequate warning devices (alarms) were not provided to indicate cycle faults detected by the Datacon Monitoring System. This system was ineffective in alerting employees to abnormal or fault conditions on or about January 27, 1992. l) Maintenance and Operating Manuals for the sterilizers were not complete and current, on or about March 5, 1992. m) Manuafacturer's (vendors) literature indicating re- commended calibration/maintenance procedures or expected service life was not available for the critical process equipment, including the pressure vacuum gauges, drain RTD, and interlocks on or about January 27, 1992. n) Sterilizer #2 was not registered with the Pennsylvania Department of Labor & Industry, Boiler Division to insure required pressure vessel inspection were received in ac- cordance with the Commonwealth of Pennsylvania requirements for unfired pressure vessels, on or about January 27, 1992. o) The drain line on Sterilizer #2 was missing a strainer thus allowing a plastic bottle cap to obstruct the opening, on or about April 6, 1992. p) Manufacturer's (Pharmetics) recommended maintenance procedures were not developed or implemented. These pro- cedures for the sterilizers include: 1. Inspecting the chamber daily for broken galssware and stoppers and to remove any debris, before operating the sterilizer. 2. Removing, inspecting and cleaning the drain screen daily. 3. Removing and cleaning the drain strainer (on a weekly basis. 4. Chamber door gasket cleaning. 5. Lubrication of door hinges. 6. Solenoid valve maintenance and repair, on or about March 4, 1992. q) The "Hazard and Operability Study" (HAZ-OP) conducted by the company on each of the sterilizers was not conducted in accordance with generally recognized process safety practice, on or about March 4,1992. r) The pressure guage on No. 4 sterilizer was disimilar to the pressure guages on sterilizers No. 3 & 3 in that it had a pressure range of 0-100 psig with numerical markings every 20 pounds and increment markings every 2 psig, on or about April 9, 1992. s) The pressure/vacuum indicator was capable of being isolated from the system by a lever operated ball valve on or about January 27, 1992. t) An unlabeled interlock reset button located on the relay box (warehouse side) was readily accessible to operators and other employees, on or about April 9, 1992. Among other methods, one feasible and acceptable abatement method to correct this hazard include: 1. Implementation of a system to identify, report, evaluate, and correct any process outside of acceptable limits, and equipment malfunctions to assure safe operation. (Instances (a) & (e)). 2. Thorough prestart-up testing of system controls on the sterilizers to assure the controls are operational and functioning according to design and safety specifications. (Instance (b)). 3. Development and implementation of a preventative maintenance program to include all critical process equipment. Preventative maintenance should be performed according to manufacturers specifications and more frequently as necessary, based on maintenance history. (Instances (c) (d) & (e)). 4. Review of process run tapes daily to identify paper jams and when ribbon needs to be changed to ensure that information is not lost and that faults are quickly revealed and remedied. (Instances (f), (g)). 5. Development and Implementation of an engineering/maintenance audit program covering critical process and safety equipment, including assignment of oversight responsibility to ensure that corporate standards are implemented and where deviations occur, variances are written and approved. (Instance (h)) The following elements should be included in this program: 1) Documented findings with communication to the department. 2) Establishment of specific time frames for corrective action. 3) Tracking and assurance of corrective action. 4) Records maintenance 6. Implementation of operators and supervisors training to recognize the hazards of upset/abnormal cycle operation including procedures to be followed to return the system to a safe operating condition, shutdown procedures and any actions to be avoided. All employees should receive prerequisite training resulting in employee certification following successful completion of the training. The training provided should be in writing outlining the information provided so that the program can be reviewed and updated as changes/alterations to the process occur and to ensure that the program is developed and implemented consistently. (Instance (i)). 7. The standard operating procedure(s) should be revised to specifically and accurately reflect employee job requirements. The procedure(s) should also address contingencies related to abnormal sterilizer operations. (Instance (j)). 8. Readily noticable audible and/or visual alarms should be installed to warn operators/supervisors of cycle conditions outside normal operating parameters. (Instance (k)). 9. Maintenance and opeating manuals received from vendors shoudl be reveiwed prior to startup of the equipment to assure that the information provided is complete and accurately reflects the operations. (Instance (l)). 10. Manufacturers/vendors information should be obtained on all critical equipment to assure recommended maintenance/calibration procedures are being followed and that inservice life of the equipment is known. (Instance (m)). 11. Assure that all pressure vessels are listed with Merck and Company's insurance carrier (who has responsibility for conducting required inspections) and that these vessels are registered with the Commonwealth of Pennsylvania. (Instance (n)). 12. Maintenance procedures shold e developed and implemented to address all manufacturer's recommendations for the system. Where re- commended procedures are not developed, this action should be mutually agreed upon by the manufacturer. (Instances (o) & (p)). 13. A detailed process hazard analysis should be performed by a team with expertise in engineering and process operations and should include at least one employee who has experience and knowledge specific to the process being evaluated. (Instances (o) & (q)). 14. Instrumentation, such as pressure guages, for the sterilizers should be of consistant design and function and incorporate the following features: 1. Capability to read vacuum. 2. Increment markings no greater than 1 psig. 3. Sufficient range to monitor both normal/abnormal conditions. 4. Adequate in number to appropriately monitor conditions. (Instance (r)). 15. Isolation valves which if closed may prevent employees from receiving critical process information should be locked or sealed in the open position during cycle opertion. (Instance (s)). 16. The interlock reset button should be located where it can be guarded against inadvertant or inappropriate activation, and a written sign-off/authorization procedure should be established to control and monitor bypass of the interlock system. (Instance (t)).