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TissueSAFE plus & SealSAFE

Biospecimen vacuum sealing
plus automated fixative addition

TissueSAFE plus & SealSAFE

Biospecimen vacuum sealing plus automated fixative addition

Problem

The International Agency for Research on Cancer (IARC) has classified formaldehyde as a class 1 carcinogen. This classification is encouraging health authorities, surgical staff, pathologists and histotechnicians to look for ways to eliminate the substance from work environments. Critical exposure points for facility personnel are the operating suites and during the transfer of formalin-fixed tissues to the pathology lab.


Solution

Elimination or control of formalin exposure/volume from the surgery room to the lab.

TissueSAFE plus *

TissueSAFE plus *

TissueSAFE plus is an innovative, patented vacuum system, which ELIMINATES formalin in the operating theatre and allows a controlled formalin-free transfer of biospecimens to the laboratory. Immediately after the excision, specimens are transferred to an adjacent room where the TissueSAFE plus is installed. Tissue is placed into sterilized vacuum-sealed specimen bags. "Fresh" specimens arrive and the fixation procedures can now take place under controlled conditions in the laboratory.

  • No formalin fumes
  • Specimens are held in “fresh” conditions
  • No spilling
  • Original specimen colors are preserved
  • Drying of tissues is eliminated

* European Patent EP 2 070 410 B1, US Patent US 8,110,346B1

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HOW TO ELIMINATE FORMALIN IN SURGICAL SUITES

Step 1

 Step 1
Tissue is placed into sterilized vacuum-sealed specimen bags and sealed under vacuum. Activate the Temperature Monitoring System to track time and temperature.

Step 2

 Step 2
Place the data logger in the transfer cart at 2-4 °C.

Step 3

 Step 3
Place the bag containing the specimen in the chamber and close the cover. Specimens are placed in single use special vacuum-sealed bags. Use the pre-printed note field or sealable document pouch to include patient data.

Step 4

 Step 4
A label is printed with the name of hospital ID code of the specimen, date, time and all relevant information. The label is glued to the sealed bag.

SealSAFE **

SealSAFE **

The SealSafe is the world’s first automatic system that fills dedicated bags containing the biospecimens, with the required fixative (i.e. formalin), in a standardized and documented way. The innovative, patented SealSAFE technology allows operators in surgery rooms and in pathology laboratories to handle histology specimens in full safety.
Today’s manual operations to prepare, transport and stock histology specimens can be drastically improved with this disruptive technology.

  • Standardization and quality
  • Reduces the volume of formalin
  • Full automation prevents exposure to formalin fumes
  • Storage in vacuum-sealed bags dramatically reduces volume
  • Extreme cost saving for disposal

** European Patent EP 2 524 595 B1 - US Patent US 8,865,092 B2

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BIOSPECIMEN MANAGEMENT: SAFETY AND AUTOMATION STANDARDS.

Step 1

 Step 1
Place specimen in the vacuum bag and introduce it into the SealSAFE cavity. Close the lid.

Step 2

 Step 2
A load cell in the cavity automatically weighs the specimen. According to a preset ratio (1:1, 1:2, 1:2.5, 1:3) the fixative is then injected into the bag.

Step 3

 Step 3
Concluding the process, the SealSAFE vacuum seals the specimen bag. Fixative injection and sealing process are completed in the closed and ventilated cavity.

Step 4

 Step 4
The sealed bag containing the specimen with full documentation is transported to the pathology lab in full safety. The same bag can be resealed up to three times from the operating theatre to the final storage.



Innovative workflow

The traditional procedures of collection, transportation and archiving of pathology specimens are specific at each institution. The introduction of TissueSAFE plus and SealSAFE technology at the starting point of sample generation (the surgery room), pathology accessioning, and in the grossing area provides a dynamic and flexible solution with benefits to all the departments involved.

1 Surgery - 2 Transfer

1 Surgery - 2 Transfer

In a dirty surgical room, the TissueSAFE or SealSAFE plus are used to vacuum seal biospecimens for transportation to the pathology laboratory. The operator can select the desired procedure for specimen management: fixative-free vacuum sealing or automated filling of the fixative plus vacuum sealing. Time and temperature conditions during transportation are monitored with a dedicated electronic data-logger, activated by the operator at the starting point. In case of vacuum sealing without the addition of the fixative, transportation and storage at +4°C are required. In this modality, optimal preservation of the molecular material of the specimen is guaranteed up to 72 hours.

3 - Pathology Lab

3 - Pathology Lab

Accessioning

As specimens arrive into pathology and are processed through accessioning, relevant data can be downloaded and saved for future use. A detailed profile of transportation temperature conditions, duration of storage, and additional identification information is viewable and easily associated with patient cases.

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4 - Pathology Lab

4 - Pathology Lab

Grossing/Sampling

At the pathology laboratory, the specimen is received in a standardized fixative quantity or in “fresh” conditions. The sampling and grossing procedures are therefore carried out without necessary modifications of the current procedures.

5 - Pathology Lab

5 - Pathology Lab

Extended Fixation/Storage

Installing a TissueSAFE plus or SealSAFE unit in the pathology laboratory enables maximum flexibility for specimen management. Moreover, SealSAFE reusable vacuum storage bags allow multiple openings and sealing events, which can accommodate:
A. Status pre-examination of large case specimen fixation/hardening.
B. Receipt, grossing and final storage of medium-sized specimens.
C. Well fixed tissues can be sealed with minimal amounts of formalin or simply vacuum-sealed to achieve drastic cost and space savings.



Special vacuum-sealed bags

From operating room to final storage

Special Vacuum Bags
  • A - A double layered PA/PE, 135 microns in thickness guarantees greater mechanical flexibility and resistance to perforation. Available in five different dimensions, suitable for all kinds of specimen
  • B - Three sealing areas and cutting lines marked for multiple reuse
  • C - A sealable document pouch provides security for patient information
  • D - The automatically printed adhesive label contains: ID, date, time, specimen and fixative weight
  • E - Enlarged base for self-standing (only for SealSAFE)

FormSAFE

Grossing Devices



Optimal morphological preservation for up to 72 hours

All specimen tissues

All tissue types have been preserved under vacuum packing (colon, gall bladder, spleen, kidney, thyroid, breast etc...) for up to 48-72 hours with optimal histological preservation.

Excellent H&E, HC, IHC, FISH staining properties

Over a thousand cases, using vacuum preservation, were tracked at the Molinette University Hospital in Turin, Italy. Morphological preservation and immunohistochemical reactivity were excellent and no adverse effects from the process were noted.

 

H&E

H&E

Adenocarcinoma of the colon.
The specimen was preserved under vacuum packing at 4°C for 48h, and then routinely processed with formalin fixation and paraffin embedding. The structure is preserved and the diagnosis is feasible. H&E x 150

IHC

IHC

Infiltrating ductal breast carcinoma.
The tissue specimen, removed on Friday afternoon, was preserved under vacuum packing at 4°C until Monday morning (64h), then routinely grossed, fixed and processed. The histological structure is well preserved. Staining for HER2 antigen (Herceptest TM by DAKO) shows a continuous membrane staining in >30% of cells (3+score).

FISH

FISH

Infiltrating ductal breast carcinoma.
The tissue specimen was preserved for 64h under vacuum packing, at 4°C. Dual-color FISH demonstrates an amplification of the HER 2 gene (red signal).


Molecular studies. Biobanking.

The quality of RNA preservation is of course related to the time of processing, but even tissues preserved under vacuum packing at 4°C for 48 hours provided nucleic acids of acceptable quality. This finding is in agreement with reports on the stability of RNA in non-fixed ice-preserved surgical specimens.
Colon mucosa either (A) frozen immediately after removal or (B) preserved under vacuum at 4°C for 48 h. (a) shows 1% denaturing agarose gel of total RNA running: the 18s band is visible and no degradation is appreciable. (b) represents RT-PCR products of cytokeratine 20mRNA of different BP number.
The upper band (arrow) is related to a 716-bp product.

Molecular studies. Biobanking.



MileWATCH: 24/7 Unit surveillance system


MileWATCH system

MileWATCH is a 24/7 units surveillance appliance that continuously monitors and controls Milestone units throughout day and night. Status Information are collected from units installed in both Operating Theaters and Pathology Laboratory. This, in turn, also helps having a better planning of the Laboratory daily work.

Compatible with existing Laboratory PC and Server, MileWATCH works without the need of an internet connection: all the related information is securely stored within the local LAN.

MileWATCH offers the possibility to create a unique samples’ Chain of Custody, from the Operation Theater, preserving evidence of the case ID, formalin ratio used , temperature and time of the transportation, until tissues have arrived to the Pathology Lab. Tissue processing protocol details and  nal storage information info will also be collected by MileWATCH and sent to local LIS (Laboratory Information System).

What sets us apart?

  • MONITOR THE PROCESS IN REAL TIME
  • BE NOTIFIED BY EMAIL
  • GET EVENTS LOG AND LOG FILE
  • SORT DOCUMENTATION BY PATIENTCASE ID
  • INTEGRATE INTO THE LIS

Remote monitoring

MileWATCH software provides extended instrument control from outside the laboratory with live view of the units screen. This allows the remote monitoring of every process status during night and day. An instant audio visual alert provides assistance 24 hours a day, 7 days a week. Moreover, all units are connected to server for a prompt transfer of process documentation. All documentation is related to the Patient-Case ID.

E-mail notification system

MileWATCH can be set to send live e-mail notification to the interested parties providing all the necessary information for a prompt action to assure trouble-free operations. Recipients can be customized based on notification type. At the end of the program, an e-mail automatically notifies mayor occurrences (events log and log file) to the service personnel and protocol status to the laboratory manager.

LIS integration

Accurate and precise process documentation can be automatically collected and directly transferred by interfacing MileWATCH to the LIS (Laboratory Information System) through the local LAN. It can be stored and retrieved, sorting by Case ID.

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Video

Watch our video to discover our product in action! Whatever your choice of fixation protocols is, TissueSAFE plus can help.

Catalog

Take a moment to consult our catalog to learn all the advantages of Milestone TissueSAFE plus.

TissueSAFE plus

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