Sabratek 

ROCAP
 
ROCAP Frequently Asked Questions
Competitive Product Profile
Product Catalog
Responding to the needs of today's pharmacies

Outsourcing Production & Distribution

Capping Drug Expenses

Assurance of Quality

Pathways for Clinical Management

 

Company Background

ROCAP produces and markets prepackaged injectable prescription pharmaceuticals (intravenous or I.V. Admixture products) and pre-filled I.V. flush syringes for the alternative site and acute-care markets.

Ready To Use Intravenous Flush Syringes

ROCAP ADVANTAGES:

Syringe Pressures

Different size syringes can generate different pressure when used to flush catheters or infuse fluid. Using a constant plunger force of 3.5 lbs. our flush syringes generate the following internal pressure:

3cc.........37psi             6cc.......... 19psi             12cc............12psi

 

Technical Information

Syringe Materials: Polypropylene plastic

Closures: Luer lock with tip cap or blunt tip cannula

Sterility: Sterile, non-pyrogenic fluid and fluid path

Administration: For single use only, for intravenous flush only; see package insert

Packaging: Individually wrapped, 30 per box; 4 boxes per case

                    Kits = 2 Normal Saline + 1 Heparin Syringe Per Pack.  Total = 30 per Box
 

ROCAP: Frequently Asked Questions
 
 

Q:  Who regulates ROCAP?

A:  ROCAP is registered with the Food and Drug Administration (FDA).

 FDA Registration
                                        ( Woburn, MA #1224788)
 
                                        ( Orlando, FL #1063005)
 
 
 

Q:  What are the specifications of the ROCAP manufacturing facilities?

A:  Aseptic processing of all ROCAP products is conducted within a Laminar Flow Clean Bench
(LFCB) certified at "class 100".  All LFCB equipment is situated in a clean room core certified
"class 1000 at operation".  All LFCB's are certified by an independent firm every six months.  The
clean room facility is certified by an independent firm annually.  ROCAP has an extensive
environmental monitoring program to include particle counts, air sampling and surface sampling
for microbial growth.
 
 

Q:  What quality control elements are in place at ROCAP?

A:  ROCAP has a quality control plan which includes a routine list of quality control activities
designed to insure the integrity of our products.  The quality plan includes, but is not limited to, in
process quality checks, end product sterility testing, environmental biological testing,
environmental controls and environmental monitoring.  Operator technique and equipment
function are continuously validated through growth media validation runs.  Fluid transfer
equipment is further validated by volumetric testing.  The content of the quality plan is based on
USP and FDA recommendations.
 
 

Q:  How has the stability of Heparin and Normal Saline products been verified?

A:  ROCAP has contracted with an FDA regulated laboratory to execute a protocol of sterility and
stability assays to substantiate expiration dating.  Assays to verify Heparin activity as well as
Sodium Chloride content have been performed.  Sterility testing has been performed at the
beginning and end of the study period to verify package integrity.  Microbial ingress testing has
also been performed.  The products were found to be within the required standard set as defined
by USP XXIII.
 
 

Q:  Are ROCAP Heparin and Normal Saline products preservative free?

A:  All Normal Saline Products contain no preservatives.  Heparin products contain trace
amounts of methylparaben and propylparaben.  The most concentrated formulations contain a
final concentration of methylparaben  0.00075% and propylparaben 0.000075%.  The products
contain no benzyl alcohol.
 
 

Q:  Are ROCAP Heparin and Normal Saline products covered by Medicaid?

A:  ROCAP has entered into the required agreements with HCFA to facilitate Medicaid
reimbursement.  The effective date of this eligibility is October 1, 1996.
 
 

Q:  What is the correct NDC code configuration for ROCAP products?

A:  All ROCAP products carry a ten digit NDC code.  The code has three segments.  The first
segment is a five digit labeler code which is unique to ROCAP.   All ROCAP products carry this
same five digit code.  The second segment is a four digit product code and the third segment is
a one digit package code.  An example is offered.

NDC 62338-0902-3  Normal Saline 2ml fill in 3ml Syringe.  #30/Box

In the above example, "62338" denotes ROCAP as the manufacturer.  The product description
"Normal Saline 2ml fill in 3ml Syringe" carries the product code "0902" and the package size
"30/Box" is indicated by the package code "3".

Some states may require an eleven digit NDC code submission for Medicaid reimbursement.   In
this case, a lead zero should be inserted before the package code.
 
 

Q.  Are ROCAP Heparin and Normal Saline products latex free?

A:  The luer lock syringe currently in use is latex free.   The manufacturing process, however,
involves component material which contains latex.  ROCAP flush syringe products are not latex
free.
 
 

Q:  Are ROCAP Heparin and Normal Saline products sterile?

A:  All Heparin and Normal Saline products are sterile.  The fluid and fluid path are sterile.  The
outer package, polyethylene bag and syringe exterior are not sterile.
 

ROCAP: Competitive Product Profile
 
 
Characteristic ROCAP TUBEX CAPUJECT SOLO-PAK
Sizes:  3 mL
 		 Yes Yes Yes Yes
5/6 mL
 		 Yes Yes Yes Yes
10/12 mL
 		 Yes No No Yes
Assembly Required: No Yes Yes Yes
Luer Lock Connection: Yes No Yes Yes
Oversize Syringes: Yes No No No
Pre-attached plunger: Yes No No No
Cost Competitive: Yes Not Now Not Now Not Now
 
 
ROCAP: Product Catalog

Intravenous Flush Syringes and Combination Packages with Luer Lock
Normal Saline
Heparin 10 Unit/ml 
Heparin 100 Unit/ml
Flush Syringes
Flush Syringes
Flush Syringes
RAS-02-03 2 ml fill in a
NDC# 62338-0902-3 3 ml syringe
RAS-03-06   3 ml fill in a RAH-03-06-10   3 ml fill in a RAH-03-06-100   3 ml fill in a
NDC#62338-0913-3   6 ml syringe NDC#62338-1013-3   6 ml syringe NDC#62338-1103-3   6 ml syringe
RAS-05-06   5 ml fill in a    
NDC#62338-0915-3   6 ml syringe
RAS-05-12   5 ml fill in a RAH-05-12-10   5 ml fill in a RAH-05-12-100   5 ml fill in a
NDC#62338-0905-3   12 ml syringe NDC#62338-0015-3   12 ml syringe NDC#62338-0105-3   12 ml syringe
RAS-10-12   10 ml fill in a    
NDC#62338-0910-3   12 ml syringe
 

 
*Combination
*Combination
Packages Heparin
Packages Heparin
10 Unit/ml
100 Unit/ml
RAK-03-06-10 3 ml fill in a RAK-03-06-100 3 ml fill in a
NDC#62338-3369-1 6 ml syringe NDC#62338-3367-1 6 ml syringe
RAK-05-12-10 5 ml fill in a RAK-05-12-100 5 ml fill in a
NDC#62338-3529-1 12 ml syringe NDC#62338-3527-1 12 ml syringe
 Intravenous Flush Syringes and Combination Packages with Blunt Tip Cannula
Normal Saline
Heparin 10 Unit/ml 
Heparin 100 Unit/ml
Flush Syringes
Flush Syringes
Flush Syringes
RAS-03-06B   3 ml fill in a RAH-03-06-10B   3 ml fill in a RAH-03-06-100B   3 ml fill in a
NDC#62338-5913-3   6 ml syringe NDC#62338-5123-3   6 ml syringe NDC#62338-5113-3   6 ml syringe
RAS-05-06B   5 ml fill in a    
NDC#62338-5915-3   6 ml syringe
RAS-05-12B   5 ml fill in a RAH-05-12-10B   5 ml fill in a RAH-05-12-100B   5 ml fill in a
NDC#62338-5905-3   12 ml syringe NDC#62338-5015-3   12 ml syringe NDC#62338-5015-3   12 ml syringe
RAS-10-12B   10 ml fill in a    
NDC#62338-5910-3   12 ml syringe
 
 
*Combination
*Combination
Packages Heparin
Packages Heparin
10 Unit/ml
100 Unit/ml
RAK-03-06-10B 3 ml fill in a RAK-03-06-100B 3 ml fill in a
NDC#62338-6369-1 6 ml syringe NDC#62338-6367-1 6 ml syringe
RAK-05-12-10B 5 ml fill in a RAK-05-12-100B 5 ml fill in a
NDC#62338-6529-1 12 ml syringe NDC#62338-6527-1 12 ml syringe

*Combination packages contain one heparin and two normal saline flush syringes

Additional syringe fill volumes may be available. Please contact your salesperson or Sabratek Customer Service at 800-556-7722.