OSHA Inspection: MERCK & COMPANY, INC.

Issued

Jun 15, 1992

Abate by

Jun 29, 1992

Penalty

Initial $2,250 · Current $1,125 Reduced

Issued

Jun 15, 1992

Abate by

Jul 15, 1992

Penalty

Initial $70,000 · Current $56,875 Reduced

General-duty citation text

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)).

Issued

Jun 15, 1992

Abate by

Jun 22, 1992

Penalty

Initial $1,000 · Current $1,000